Day

December 1, 2021
Company: Philips Healthcare Date of Enforcement Report: 12/1/2021 Class II PRODUCT Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) Recall Number: Z-0238-2022 REASON 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging....
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 12/1/2021 Class II PRODUCT Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135 Recall Number: Z-0296-2022 Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model...
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Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 12/1/2021 Class II PRODUCT Medtronic CareLink SmartSync Device Manager application software (D00U005) used by Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR: DVPB3D1, DVPB3D4; Cobalt XT DR: DDPA2D1, DPA2D4;...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 12/1/2021 Class II PRODUCT SOMATOM Force with software syngo.CT VB20 Model #10742326 Recall Number: Z-0283-2022 SOMATOM Definition AS with software syngo.CT VB20 Model #8098027 Recall Number: Z-0284-2022 SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000 Recall Number: Z-0285-2022 SOMATOM Definition Flash with software syngo.CT...
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Company: Abbott Laboratories Date of Enforcement Report: 12/1/2021 Class II PRODUCT ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89 Recall Number: Z-0271-2022 ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77; Recall Number: Z-0272-2022 REASON Twelve software-related issues affecting software...
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Upcoming SoftwareCPR Training Courses:

Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

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

Instructors: Dr. Peter Rech, Brian Pate

Discount Registration through October 31, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/2023-softwarecpr-public-training-course–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610

 

Public Course – Dec 12-15, 2022 – Being Agile & Yet Compliant (virtual)

COST: 4 half days for $1,920 per person

HOURS: 11 am until 3 pm EDT each day

TRAINING LOCATION: Virtual – live online

Register here:

https://events.eventzilla.net/e/december-2022-softwarecpr-agile-and-compliant-training-course-2138573767

 

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