November 4, 2020
Company: GE Healthcare, LLC Date of Enforcement Report: 11/4/2020 Class II PRODUCT Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 – Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Recall Number: Z-0306-2021 REASON There is a potential for a smudge artifact that could be suspect...
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Company: Merge Healthcare, Inc. Date of Enforcement Report: 11/4/2020 Class II PRODUCT Merge LIS Recall Number: Z-0289-2021 REASON A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc. on 1/23/2017. Voluntary:  Firm...
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Company: Pentax of America Inc Date of Enforcement Report: 11/4/2020 Class II PRODUCT 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), Recall Number: Z-0292-2021 REASON There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B)....
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Updated Risk Management training course now available.  Includes:

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

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