July 21, 2021
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: ...
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Latest News!

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!

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

Corporate Office

15148 Springview St.
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN, TX) and Canada.