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Company: Deltec, Inc.Date of Enforcement Report: 7/23/03 Class: II PRODUCT Deltec CASS-Prizm PCS II Ambulatory Infusion Pump with Revision E Software. Recall # Z-0980-03. REASON Pump keyboard entries by the patient can result in the patient having unintended access to programming screens and result in improper drug dosage. CODE Pump Serial numbers 658825, 658837, 658840,...
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Company: Siemans Medical Solutions USA, IncDate of Enforcement Report: 7/23/03 Class: II PRODUCT Axiom Sensis. Programmable Diagnostic Computer. Recall # Z-0979-03. REASON Software problem – erroneous results or system crashes. CODE Part numbers 6623974 and 6634633. Serial numbers 06011, 06012, 06018, and 02016. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions, USA, Inc., Malvern, PA, by letter in...
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Company: Siemans Medical Solutions USA, IncDate of Enforcement Report: 7/23/03 Class: II PRODUCT Acuson Cypress Echocardiography System, Imaging System. Catalog # 8264604. Recall # Z-0975-03. REASON Software problem – loss of data. CODE Serial numbers 70000 through 72000. RECALLING FIRM/MANUFACTURER Siemans Medical Solutions USA, Inc., Plymouth Meeting, PA, by letter dated April, 2003. Firm initiated...
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Company: South Texas Blood and Tissue CenterProduct: Blood facility Date: 7/17/03 Your facility failed to check input to and output from its computer and related systems for accuracy [21 CFR 211.68(b)]. For example, Your facility’s _____ computer system and _____ lacked controls or procedures to prevent improper sample analysis or mix-ups. As explained above (1.a),...
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Company: Draeger Medical, Inc.Date of Enforcement Report: 7/16/03 Class: II PRODUCT Evita 4 Continuous Ventilator. Catalog numbers 4116640 and 8412980. Recall # Z-0954-03. REASON Software problems – ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm. CODE Software version 4.00 or 4.10. RECALLING FIRM/MANUFACTURER Draeger Medical, Inc., Telford, PA,...
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Company:Fujifilm Medical System USA, Inc.Date of Enforcement Report: 6/25/03 Class: II PRODUCT Synapse. Recall # Z-0932-03. REASON Synapse Version 2.2.1 and 2.3.1software (Free-Hand Region) may lead to incorrect density calculations during CT scan. CODE Version 2.2.1 and 2.3.1. RECALLING FIRM/MANUFACTURER Fujifilm Medical System USA, Inc., Stamford, CT, by letter during the week of May 12,...
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Company:Canon USA, Inc.Date of Enforcement Report: 6/25/03 Class: II PRODUCT Rational Imaging TM Software, model Ultra 10 PACS System. Recall # Z-0905-03. CODE RIUpdate 7.1.OK. RECALLING FIRM/MANUFACTURER Canon USA, Inc., Irvine, CA, by letters on March 11, and March 26, 2003. Firm initiated recall is ongoing. REASON Imaging archive system software mismatches images and patient...
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Company: MagneVu Product: Portable magnetic resonance imaging (MRI) system Date: 07/11/03 Software validation activities for computers or automated data processing systems used as part of production have not been performed or documented [21 CFR 820.70(i)]. Specifically, the Eng MagMRI software used for engineering and servicing of the MagneVu 1000 MRI System has not been validated....
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Company: Roche Molecular Systems, Inc.Date of Enforcement Report: 6/11/03 Class: II PRODUCT COBAS TaqMan analyzer, Series 96; catalog number 8080216. Recall # Z-0917-03. REASON A false positive result may be reported. CODE All units with software versions TaqLink v 1.0 or TaqLink v 1.1. RECALLING FIRM/MANUFACTURER Roche Molecular Systems, Inc., Belleville, NJ, by telephone, and...
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Company:Guidant Corp-Cpi Division.Date of Enforcement Report: 6/11/03 Class: II PRODUCT a) Pulsar Multiprogrammable Pacemaker, DDD Model 970. Recall # Z-0875-03; b) Pulsar Multiprogrammable Pacemaker, DDD Model 972. Recall # Z-0876-03; c) Pulsar Multiprogrammable Pacemaker, DDD Model 976. Recall # Z-0877-03; d) Pulsar Multiprogrammable Pacemaker, DDDR Model 1270. Recall # Z-0878-03; e) Pulsar Multiprogrammable Pacemaker, DDDDR...
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Company: Philips Medical Systems (Cleveland) IncDate of Enforcement Report: 6/04/03 Class: III PRODUCT a) Philips MX8000 IDT CT Scanner, utilizing V2.1 software. Recall # Z-0835-03; b) Philips MX8000 Dual v, Exp CT Scanner, utilizing V2.0 software. Recall # Z-0836-03; REASON Patient images may be incorrectly stored in the archive directory of a different patient. CODE...
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Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/04/03 Class: III PRODUCT a) Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; Catalog Numbers: 23656 (New), 45441 (Refurb). Recall # Z-0864-03; b) Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use...
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Company: Philips Medical Systems (Cleveland) IncDate of Enforcement Report: 5/28/03 Class: III PRODUCT a) Philips MX8000 IDT CT Scanner, utilizing V2.1 software. Recall # Z-0835-03. b) Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software. Recall # Z-0836-03. REASON Patient images may be stored in the archive directory of a different patient. CODE a)...
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Company: Abbott Laboratories, IncDate of Enforcement Report: 5/28/03 Class: II PRODUCT a) Gemstar_ 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2.9 Software Version. Recall # Z-0792-03; b) Gemstar_ 6 Therapy I.V. Infusion Pump, List#: 13100-04; 2.9 Software Version. Recall # Z-0793-03; c) Gemstar_ Therapy Pain Management I.V. Infusion Pump, List#: 13150-04; 2.9 Software Version. Recall...
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Company: Deltec, Inc.Date of Enforcement Report: 5/28/03 Class: II PRODUCT Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3 versions vary only in the color of the exterior. Recall # Z-0798-03. REASON A software error can result in the delivery of a larger bolus of insulin than anticipated when...
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Company: Misys Healthcare SystemDate of Enforcement Report: 5/28/03 Class: III PRODUCT Misys Commercial Laboratory, Laboratory Information System. Recall # Z-806-03. REASON Software logic error. Dates were printing incorrectly on cumulative reports. CODE Version 3.4.1. RECALLING FIRM/MANUFACTURER Misys Healthcare System, Plano, TX, by letter on March 13, 2003. Firm initiated recall is complete. VOLUME OF PRODUCT...
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Company: Siemens Medical Solutions USA, IncDate of Enforcement Report: 5/28/03 Class: II PRODUCT a) Leonardo MM-WS systems. System, Image Processing. Recall # Z-0841-03; b) Smatom Sensation 16, Computed Tomography System, Diagnostic Imaging. Recall # Z-0842-03. REASON Perfusion CT is displaying a higher gray and color values than normal. A software problem. CODE a) Model Number...
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Company: Beckman Coulter, Inc.Date of Enforcement Report: 5/28/03 Class: III PRODUCT COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use. Recall # Z-0805-03. REASON Software problem may cause the instrument to skip the probe-wash step before processing different reagents. CODE All existing versions of the software. Serial numbers PrepPlus 0006026440 and above...
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Company: Misys Healthcare SystemsDate of Enforcement Report: 5/28/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0804-03. REASON Software anomaly may result in incorrect values and interpretations. CODE Versions 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on March 27, 2003. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...
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Company: Abbott Laboratories, IncDate of Enforcement Report: 5/21/03 Class: II PRODUCT AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01. Recall #Z-0788-03. REASON Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride. CODE All lots. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX,...
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On February 20, 2003, a final security rule 45 CFR Part 142 was issued. A copy is at this link: HIPAA Final Security Rule 2003-02. Medical Device manufacturers that produce devices that will maintain patient data should be aware of HIPAA privacy and security requirements to assure appropriate features are incorporated in their devices to...
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A presentation of a proposal for EU software regulation at the ISPRA meeting on Medical Device Software May 13, 2003, is at the link provided. Some of the suggestions are based on FDA guidance documents. ISPRA Meeting on SW This presentation was provided by Poul Schmidt-Andersen of Copenhagen Medical Devices, which is an affiliate of SoftwareCPR....
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Company: ConMed Corp. Product: Hyfrecator 2000 and other electrosurgical devices and accessories Date: 05/08/2003 Failure to validate computer software for its intended use according to an established protocol prior to approval and issuance, and document the results of these validation activities, as required by 21 CFR 820.70(i). For example, a software program used to run...
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Company: Antelope Valley Healthcare District Product: Blood and blood components Date: 05/01/2003 Specifically, the procedure “Donor Registration and Medical Interview,” which includes instructions for entering deferral information into the computer system based on disqualifying information provided during the donor screening process, does not provide details concerning the documentation of information (such as exposure dates) so...
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Company: Siemens Medical SolutionsDate of Enforcement Report: 4/30/03 Class: III PRODUCT ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems. Recall # Z-0727-03. REASON ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions. CODE All Diacam, Multispect...
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Company: Abbott Laboratories, IncDate of Enforcement Report: 4/30/03 Class: III PRODUCT Aeroset Software versions 1.00ER005, catalog number 2-89996-01; and software version 1,00ER005.2, catalog number 2-89996-02. Recall # Z-0725-03. REASON Under certain operating conditions, smart wash feature disables with multiple samples. CODE No codes. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX, by letter on February 24,...
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Company: Misys Healthcare SystemsDate of Enforcement Report: 4/23/03 Class: III PRODUCT Misys Laboratory_ Blood Bank System computer software (3 versions). Recall # B-0791-3. REASON Blood bank computer software contained a defect that could result in the incomplete displaying of red blood cell antigen and antibody information for a unit of blood. CODE Version numbers 5.2,...
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Company: Misys Healthcare SystemsDate of Enforcement Report: 4/9/03 Class: II PRODUCT Misys Laboratory System Version 5.3. Recall # Z-0670-03. REASON Software anomaly. The HIDE command used to suppress suspected individual microbiology observations does not work in GUI inquiry. CODE Version 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on February 19, 2003. Firm...
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Company:Beckman Coulter, IncDate of Enforcement Report: 4/9/03 Class: III PRODUCT LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645. Recall # Z-0669-03. CODE REASON Incorrect Hemoglobin result can be reported at software version 2A and higher. All instruments with version 2A or higher. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by telephone and letters...
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Company: Misys Healthcare SystemsDate of Enforcement Report: 4/9/03 Class: II PRODUCT Misys Laboratory, Calculator Data processing Module for Clinical Use. Recall # Z-0678-03. REASON Software anomally. Graphical display omits results containing a less than () or percent (%) symbol. CODE Version 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ., by fax on January 17, 2003....
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Company: Cti Pet Systems, IncDate of Enforcement Report: 4/9/03 Class: II PRODUCT ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+,ECAT ART, ECAT EMERGE and ECAT ACCEL CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT...
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A white paper at the link provided gives an overview of the status of European Union medical device software regulation and provides suggestions on software validation. Some of the suggestions are based on FDA guidance documents. CMD Swartikel This paper was provided by Poul Schmidt-Andersen of Copenhagen Medical Devices which is an affiliate of SoftwareCPR.
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Company: Misys Healthcare SystemsDate of Enforcement Report: 3/26/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0614-03. CODE Versions 5.2, 5.23 and 5.3. REASON Software anomaly. Rejecting the selected Autofiling status may result in the change being accepted rather than rejected. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on January 31, 2003. Firm...
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Company: Misys Healthcare SystemsDate of Enforcement Report: 3/26/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0626-03. REASON Software anomaly. Patient results may be filed in the incorrect patient file. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on January 31, 2003. Firm initiated recall is ongoing. VOLUME...
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Company: Misys Healthcare SystemsDate of Enforcement Report: 3/26/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0647-03. REASON Software anomaly, incorrect coding. Some comments were not transfered when coming from the Reference Laboratory Interface. CODE Version 5.3 with Reference Laboratory Interface. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Tucson, AZ, by facsimile on October 18, 2002. Firm...
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Company: Varian Medical Systems, IncDate of Enforcement Report: 3/26/03 Class: II PRODUCT VARiS 1.4G and Vision/Soma Vision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x. Recall # Z-0633*03. REASON The product has a software problem. This could result in a treatment without a motorized wedge where one had...
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Company: Advanced Radiation Measurements Inc.Product: Radiation beam scanners Date: 3/25/03 Your firm failed to validate processes whose results cannot be fully verified by subsequent inspection and test according to established procedures as required by 21 CFR 820.75. Structural testing conducted as part of your firm’s software validation, and software validation of the Scan Test used...
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/docs/MurrayPart11PresentationFoodSafetySummitMarch2003.PDF
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Company: Misys Healthcare Systems, Inc.Date of Enforcement Report: 3/12/03 Class: II PRODUCT Misys Blood Bank System. Recall # B-0581-3. REASON Defect in the design of blood bank software programs could result in the release of unsuitable blood product. CODE Version 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc. (formerly Sunquest Information Systems), Tucson,...
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Company: Baxter Healthcare, Corp..Date of Enforcement Report: 3/5/03 Class: III PRODUCT a) HomeChoice Automated Peritoneal Dialysis Systems; Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R. Recall # Z-0564-03; b) HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R. Recall # Z-0565-03. REASON Potential for low ultrafiltrate volumes...
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Company: Innovative Products Unlimited Inc.Product: Medical Device products including gurneys Date: 3/4/03 No procedures to control labeling activities, as required by 21 CFR 820.120. For example, while you maintain master labels for your gurney models, these master labels lack signatures and dates to document that they have been reviewed and approved, and there are no...
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http://www.ispe.org/page.ww?name=Welcome+to+the+ISPE+GAMP+COP§ion=GAMP+COP
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FDA issued a formal federal register notice announcing a new draft guidance for Part 11 titled “Part 11, Electronic Records, Electronic Signatures Scope and Application”. This notice also: officially withdraws not only all earlier draft Part 11 guidance documents but it also withdraws the Part Compliance Policy guide formally announces FDA’s intent to reexamine its...
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SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  June 24-26, 2025 (Boston, MA)

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Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
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  • And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

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  • Americas: 11-13 February 2025
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See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

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