By

Amy Sellers
Company:Philips Electronics North America Corporation Date of Enforcement Report 5/9/2018 Class lI: PRODUCT Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional...
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Company:PerkinElmer Life and Analytical Sciences, Wallac, OYDate of Enforcement Report 5/9/2018 Class lI: PRODUCT Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. Recall Number: Z-1397-2018 REASON Control Console software has been updated to reduce the...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. Recall Number: Z-1398-2018 REASON Control Console software has been updated to reduce the risk for collision...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer Recall Number: Z-1399-2018 REASON Control Console software has been updated to reduce the risk for collision...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT ONCOR Impression plus, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer Recall Number: Z-1401-2018 REASON Control Console software has been updated to reduce the risk for...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT ONCOR Impression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer Recall Number: Z-1400-2018 REASON Control Console software has been updated to reduce the risk for collision...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT PRIMUS HI, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer Recall Number: Z-1402-2018 REASON Control Console software has been updated to reduce the risk for collision...
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Company:GE Medical Systems Ultrasound & Primary Care Diagnostics, Date of Enforcement Report 4/25/2018 Class lI: PRODUCT GE Healthcare:a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 b) Prodigy Advanced, Model Numbers: LU42361, LU42397Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal...
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Company:GE Medical Systems Ultrasound & Primary Care Diagnostics, Date of Enforcement Report 4/25/2018 Class lI: PRODUCT 1. GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared...
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Company:Philips Medical Systems (Cleveland) IncDate of Enforcement Report 4/25/2018 Class lI: PRODUCT ngenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of...
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Company:Beckman Coulter Inc.Date of Enforcement Report 4/18/2018 Class lI: PRODUCT iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100. Recall Number Z-1366-2018 REASON iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria. RECALLING FIRM/MANUFACTURER Beckman...
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Company:Philips Electronics North America CorporationDate of Enforcement Report 4/18/2018 Class lI: PRODUCT IntelliVue X3 Patient Monitor.. Recall Number Z-1315-2018 REASON The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to...
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Company:Beckman Coulter Inc.Date of Enforcement Report 4/18/2018 Class lI: PRODUCT BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer Recall Number Z-1362-2018 REASON Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal...
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Company:Lifeline Systems Company.Date of Enforcement Report 4/18/2018 Class lI: PRODUCT HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator. Recall Number Z-1316-2018 REASON A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable. RECALLING FIRM/MANUFACTURER Lifeline Systems Company, Framingham, MA on 11/13/2017. Voluntary: Firm Initiated recall...
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Company:Beckman Coulter Inc.Date of Enforcement Report 4/18/2018 Class lI: PRODUCT AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland. Recall Number Z-1341-2018 REASON The device may process...
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Company:Fresenius Medical Care Renal Therapies Group, LLCDate of Enforcement Report 4/18/2018 Class lI: PRODUCT Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis. Recall Number Z-1365-2018 REASON The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result...
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Company:Invivo Corporation.Date of Enforcement Report 4/11/2018 Class lI: PRODUCT DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post processing software package designed...
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Company:GE HealthcareDate of Enforcement Report 4/11/2018 Class lI: PRODUCT GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or...
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Company:Fresenius Medical Care Renal Therapies Group, LLCDate of Enforcement Report 4/11/2018 Class lI: PRODUCT 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy. Recall Number Z-1278-2018 REASON...
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Company:Phadia Ab.Date of Enforcement Report 4/11/2018 Class lI: PRODUCT Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4. Recall Number Z-1276-2018 REASON We want to inform...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/11/2018 Class lI: PRODUCT Syngo.via. Medical Device Software. Picture archiving and communications system Recall Number Z-1303-2018 REASON A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving...
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Company:Baxter Healthcare CorporationDate of Enforcement Report 4/11/2018 Class lI: PRODUCT Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system.Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. Recall Number Z-1280-2018 REASON Firm has received reports of device operators failing to adhere to...
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Company:RAYSEARCH LABORATORIES ABDate of Enforcement Report 4/4/2018 Class lI: PRODUCT Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130 Recall Number Z-1275-2018 REASON Software issue with Center Beam in Field functionality. Issue can result in incorrect...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/4/2018 Class lI: PRODUCT ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL. Recall Number Z-1200-2018 REASON The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions...
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Company:Siemens Medical Solutions USA, IncDate of Enforcement Report 4/4/2018 Class lI: PRODUCT Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Recall Number Z-1261-2018 REASON When the...
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Company:St. Jude Medical, Inc..Date of Enforcement Report 4/4/2018 Class lI: PRODUCT Proclaim DRG Implantable Pulse Generator, Model Number 3664 Recall Number Z-1170-2018 REASON The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created discomfort for...
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Company:Smiths Medical ASD Inc..Date of Enforcement Report 3/28/2018 Class lI: PRODUCT The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal,...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 3/21/2018 Class lI: PRODUCT ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides...
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Company:Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report 3/14/2018 Class lI: PRODUCT A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient...
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Company:Medtronic Navigation, Inc.Date of Enforcement Report 3/14/2018 Class lI: PRODUCT O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM Bl70000028120R SYS 120V RWK, Product Number: Bl70000028120R (UDI: 00643169353459); (4)...
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Company:Abbott Point Of Care Inc.Date of Enforcement Report 3/14/2018 Class lI: PRODUCT i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255) Recall Number Z-0946-2018 REASON Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not update, and (2) Customized Reference Ranges, Action...
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Company:Philips Electronics North America Corporation Date of Enforcement Report 3/14/2018 Class lI: PRODUCT Philips Network Firewall (Cisco ASA 5506)Product Usage:The Cisco ASA 5506-X provides IPv4 and IPv6 Routing and Network Address Translation (NAT) capabilities. It also provides the following: Port Filtering Stateful Packet Inspection Default Protection Policies These default policies trust all outgoing traffic and...
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Company:ZOLL Medical Corporation Date of Enforcement Report 3/7/2018 Class lI: PRODUCT 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. Recall...
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Company:Fresenius Medical Care Renal Therapies Group, LLC Date of Enforcement Report 3/7/2018 Class lI: PRODUCT Intellivue iX Information Center Software – All PIIC iX Surveillance stations including: 866023 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy. Recall Number Z-0829-2018 REASON While reviewing documentation for the next software release of the 2008T,...
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Company:Philips Electronics North America Corporation Date of Enforcement Report 3/7/2018 Class lI: PRODUCT digital x-ray detector ProGrade R1 – solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for...
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Company:Philips Electronics North America Corporation Date of Enforcement Report 3/7/2018 Class lI: PRODUCT Intellivue iX Information Center Software – All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Database...
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A committee draft for vote of “IEC 62304 Ed 2: Health Software – Software life cycle processes” has been circulated for ballot. Edition 2 expands the scope of IEC 62304 to include health software that is not regulated as a medical device, and the title has been changed accordingly. This will be the last opportunity...
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Company:Oculus Optikgeraete GMBH Date of Enforcement Report 2/28/2018 Class lI: PRODUCT OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye Recall Number Z-0635-2018 REASON...
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Company:Zimmer Biomet, Inc. Date of Enforcement Report 2/28/2018 Class lI: PRODUCT ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons. Recall Number Z- 0638-2018 REASON Robot arm being sent to the wrong position-2018 RECALLING FIRM/MANUFACTURER Zimmer Biomet, Inc.Warsaw, IN on 5/1/2017....
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Company:Med Tec Inc Date of Enforcement Report 2/28/2018 Class lI: PRODUCT Protura Software which utilizes Elekta’s iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, and/or image guidance systems and the Protura Couch.....
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Company:Zimmer Biomet, Inc. Date of Enforcement Report 2/28/2018 Class lI: PRODUCT ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons. Recall Number Z- 0637-2018 REASON Robot arm being sent to the wrong position-2018 RECALLING FIRM/MANUFACTURER Zimmer Biomet, Inc.Warsaw, IN on 5/1/2017....
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Company: Roche Diagnostics CorporationDate of Enforcement Report 2/28/2018 Class lI: PRODUCT Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001 Recall Number Z-0675-2018 REASON A software failure may incorrectly set the system settings to “default” settings, creating a risk of incorrect results. RECALLING FIRM/MANUFACTURER Roche Diagnostics Corporation, Indianapolis, IN on 4/28/2017. Voluntary:...
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Company:Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 2/21/2018 Class lI: PRODUCT Ingenuity TF PET/CT (model 882442) running software version 4.0.2This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission...
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Company:Roche Diabetes Care, Inc. Date of Enforcement Report 2/21/2018 Class lI: PRODUCT Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017 Recall Number Z-0625-2018 REASON Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a...
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Company:Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Philips Brilliance 64 computed tomography x-ray system Recall Number Z-0518-2018 REASON Numerous issues related to software Brilliance iCT 4.1.6 software version. RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc, Cleveland, OH on 10/6/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...
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Company:Spacelabs Healthcare Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, Recall Number Z-0532-2018 REASON Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring. RECALLING FIRM/MANUFACTURER Spacelabs Healthcare Inc., Snoqualmie, WA on 1/17/2018. Voluntary: Firm...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Syngo.plaza systems with SW VB20A, Model Number – 10863171, 10863172, 10863173Product Usage:Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning....
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Company:Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Philips Ingenuity CT computed tomography x-ray system Recall Number Z-0521-2018 REASON Numerous issues related to software Brilliance iCT 4.1.6 software version. RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc, Cleveland, OH on 10/6/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...
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Company:Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Philips Ingenuity Core computed tomography x-ray system Recall Number Z-0519-2018 REASON Numerous issues related to software Brilliance iCT 4.1.6 software version. RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc, Cleveland, OH on 10/6/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...
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62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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