Recall – Radiation therapy software failure during synchronization

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:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

7

DISTRIBUTION

U.S. Nationwide

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 training@softwarecpr.com

Corporate Office

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