Tag

recall

Software Recall

Company: Elekta Inc. Date of Enforcement Report: 10/6/2021 Class II PRODUCT Elekta Monaco – Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number: Z-2563-2021 REASON Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to...
Read More
Company: Biodex Medical Systems, Inc. Date of Enforcement Report: 10/6/2021 Class II PRODUCT Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330. Recall Number: Z-2580-2021 REASON When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have...
Read More
Company: Philips Ultrasound Inc. Date of Enforcement Report: 9/29/2021 Class II PRODUCT EPIQ Diagnostic Ultrasound Systems: Software Versions: 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 – 795120, EPIQ 5C – 795205, EPIQ 5G – 795204, EPIQ 7 – 795117, EPIQ 7C – 795201, EPIQ 7G – 795200, EPIQ CVxi -795232, EPIQ CVx – 795231 Recall...
Read More
Company: Philips Ultrasound Inc. Date of Enforcement Report: 9/29/2021 Class II PRODUCT Affiniti Diagnostic Ultrasound Systems: Software Versions: 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121, Affiniti 30 795218, Affiniti 50 795208, Affiniti 50 795118, Affiniti 70 795210, Affiniti 70 795119 Recall Number: Z-2484-2021 REASON Due to a software defect that can intermittently cause the...
Read More
Company: GE Healthcare, LLC Date of Enforcement Report: 9/29/2021 Class II PRODUCT Centricity PACS-IW with Universal Viewer – Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Recall Number: Z-2502-2021 REASON Image acquisition failures and synchronization failure with the Centricity Enterprise Archive. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC...
Read More
Company: DePuy Orthopaedics, Inc. Date of Enforcement Report: 9/8/2021 Class II PRODUCT TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420578 Recall...
Read More
Company: Elekta Inc Date of Enforcement Report: 9/8/2021 Class II PRODUCT Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 Recall Number: Z-2406-2021 REASON If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the...
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 9/8/2021 Class II PRODUCT Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis...
Read More
Company: Philips Medical Systems Gmbh, DMC Date of Enforcement Report: 9/8/2021 Class II PRODUCT CombiDiagnost R90 Software Version R1.0 and R1.1 Recall Number: Z-2357-2021 REASON Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the...
Read More
Company: Merge Healthcare, Inc. Date of Enforcement Report: 9/8/2021 Class II PRODUCT Merge Hemo, Software packages 10.2, 10.3, and 10.4 Recall Number: Z-2387-2021 REASON The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc. on...
Read More
Company: Beckman Coulter Inc. Date of Enforcement Report: 9/1/2021 Class II PRODUCT Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments. Recall Number: Z-2332-2021 REASON There is a potential that the data management system may add additional cells to...
Read More
Company: Philips North America LLC Date of Enforcement Report: 8/25/2021 Class II PRODUCT 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades Recall Number: Z-2314-2021 REASON When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the...
Read More
Company: Philips Respironics, Inc. Date of Enforcement Report: 8/25/2021 Class II PRODUCT Trilogy Evo, Product numbers: BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B Recall Number: Z-2287-2021 REASON Two software issues have been identified related to pressure increase in the device: The first...
Read More
Company: Abbott Laboratories, Inc Date of Enforcement Report: 8/18/2021 Class II PRODUCT Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories. Recall Number: Z-2241-2021 REASON A design defect (hardware and software) allows liquid waste...
Read More
Company: Beckman Coulter, Inc. Date of Enforcement Report: 8/18/2021 Class I PRODUCT Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 – Kaluza C Single Perpetual License C10575 – Kaluza C Single User 1-year License C10576 – Kaluza C 10 User Network License C10577 – Kaluza C 5 User Network License C10578...
Read More
Company: Baxter Healthcare Corporation Date of Enforcement Report: 8/18/2021 Class I PRODUCT Dose IQ Safety Software used with Spectrum IQ Infusion Pump Recall Number: Z-2165-2021 REASON Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum...
Read More
Company: Simpleware Product Group, SYNOPSYS NORTHERN EUROPE Date of Enforcement Report: 8/18/2021 Class II PRODUCT Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options. Recall Number: Z-2253-2021 REASON A issue (bug) has been identified with the interface and image software which could...
Read More
Company: Baxter Healthcare Corporation Date of Enforcement Report: 8/18/2021 Class I PRODUCT Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids. Recall Number: Z-2110-2021 REASON System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System...
Read More
Company: BioMerieux SA Date of Enforcement Report: 8/18/2021 Class II PRODUCT MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data. Recall Number: Z-2225-2021 REASON Software anomaly – Under certain conditions, unwanted alterations to results could be applied when...
Read More
Company: Caption Health Date of Enforcement Report: 7/28/2021 Class II PRODUCT Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0) Recall Number: Z-2111-2021 REASON The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect...
Read More
Company: Soft Computer Consultants, Inc. Date of Enforcement Report: 7/28/2021 Class II PRODUCT SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in...
Read More
Company: Respironics California, LLC Date of Enforcement Report: 7/28/2021 Class I PRODUCT Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory...
Read More
Company: C-RAD POSITIONING AB Date of Enforcement Report: 7/21/2021 Class II PRODUCT PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0 Recall Number: Z-2075-2021 REASON PC Application Software c4D not changing site upon synchronization during the setup workflow step. RECALLING FIRM/MANUFACTURER C-RAD POSITIONING AB on 8/6/2020. Voluntary: ...
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 7/14/2021 Class II PRODUCT ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000 Recall Number: Z-2029-2021 REASON Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging...
Read More
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 7/14/2021 Class II PRODUCT The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for...
Read More
Company: Normand-Info S.A.S.U. Date of Enforcement Report: 6/16/2021 Class II PRODUCT Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments. Recall Number: Z-1831-2021 REASON Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of...
Read More
Company: CHANGE HEALTHCARE CANADA COMPANY Date of Enforcement Report: 6/9/2021 Class II PRODUCT Change Healthcare Enterprise Viewer – Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content. Recall Number: Z-1773-2021 REASON A software defect was identified where the Image...
Read More
Company: Draeger Medical, Inc. Date of Enforcement Report: 6/9/2021 Class II PRODUCT Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 – Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons. Recall Number: Z-1690-2021 REASON Three separate and unrelated problems attributed to the software used in the...
Read More
Company: Medtronic Date of Enforcement Report: 6/9/2021 Class II PRODUCT Multiple MiniMed 780G Insulin Pump Models Recall Number: Z-1771-2021 REASON Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the amount of active...
Read More
Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 5/26/2021 Class II PRODUCT RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system. Recall Number: Z-1597-2021 REASON For some LINAC types, merging clinical...
Read More
Company: Haag-Streit USA Inc. Date of Enforcement Report: 5/19/2021 Class II PRODUCT Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope. Recall Number: Z-1560-2021 REASON Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI). RECALLING FIRM/MANUFACTURER Haag-Streit USA Inc...
Read More
Company: Meridian Bioscience Inc Date of Enforcement Report: 5/19/2021 Class II PRODUCT Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file. Recall Number:...
Read More
Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 5/12/2021 Class II PRODUCT CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED). Recall Number: Z-1522-2021 CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara...
Read More
Company: Philips North America LLC Date of Enforcement Report: 5/5/2021 Class II PRODUCT Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices – intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service numbers associated with the following: FC2010: Xper Flex Cardio 2010 Rev A 453564241901 Xper Flex Cardio 2010...
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 5/5/2021 Class II PRODUCT Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese...
Read More
Company: Change Healthcare Canada Company Date of Enforcement Report: 5/5/2021 Class II PRODUCT Change Healthcare Enterprise Viewer Recall Number: Z-1508-2021 REASON Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display. RECALLING FIRM/MANUFACTURER Change Healthcare Canada Company on 3/17/2021. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF...
Read More
Company: Datascope Corp. Date of Enforcement Report: 5/5/2021 Class III PRODUCT Cardiosave Hybrid IABP – Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65 Recall Number: Z-1506-2021 REASON There are cybersecurity...
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 4/28/2021 Class II PRODUCT Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording...
Read More
Company: Welch Allyn Inc Mortara Date of Enforcement Report: 4/28/2021 Class II PRODUCT ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 – Product Usage: indicated for use on adult and pediatric populations. Recall Number: Z-1482-2021 REASON Devices do not meet IEC 60601-2-27 requirements as labeled. RECALLING...
Read More
Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 4/21/2021 Class II PRODUCT RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613) Recall Number: Z-1427-2021 REASON Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat. RECALLING FIRM/MANUFACTURER RAYSEARCH...
Read More
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 4/21/2021 Class II PRODUCT ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) – US, automated hematology analyzer Software Versions 6.10 and 6.11 Recall Number: Z-1386-2021 REASON Potential Sample Identification (SID) Mismatch with 14-Character Barcodes. RECALLING FIRM/MANUFACTURER Siemens Healthcare Diagnostics, Inc. on 3/5/2021. Voluntary:  Firm Initiated recall...
Read More
Company: Fujifilm Medical Systems U.S.A., Inc. Date of Enforcement Report: 4/7/2021 Class II PRODUCT Synapse PACS – Radiological Image Processing System – Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server). Recall Number: Z-1348-2021 REASON The wrong...
Read More
Company: Biocare Medical, LLC Date of Enforcement Report: 4/7/2021 Class II PRODUCT BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: ” Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1 Recall Number: Z-1333-2021 REASON Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction...
Read More
Company: Philips North America, LLC Date of Enforcement Report: 4/7/2021 Class II PRODUCT Philips SureSigns VM4, VM6 and VM8 – Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi”gns VM8 (863066, 863068,...
Read More
Company: Hitachi Medical Systems America Inc Date of Enforcement Report: 3/31/2021 Class II PRODUCT Ultrasonic pulsed doppler imaging system – Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph....
Read More
Company: CAIRE DIAGNOSTICS INC Date of Enforcement Report: 3/31/2021 Class II PRODUCT CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** – Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology. Recall Number: Z-1284-2021 REASON Erroneously...
Read More
Company: Biomerieux Inc Date of Enforcement Report: 3/31/2021 Class II PRODUCT VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial...
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 3/24/2021 Class II PRODUCT Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model...
Read More
Company: Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report: 3/24/2021 Class II PRODUCT Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions: 03.04.00 04.01.00 04.03.00 04.04.00 04.04.01 Recall Number: Z-1254-2021 REASON BeneVision DMS may intermittently freeze and require a...
Read More
Company: ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). Date of Enforcement Report: 3/17/2021 Class II PRODUCT ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). Recall Number: Z-1185-2021 REASON In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined...
Read More
1 2 3 59

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.