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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

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