Recall – Software issue can lead to incorrect patient positioning and dose

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 3/3/2020
Class II

PRODUCT

COHERENCE Oncologist, Model Nos. 07333680 & 07351898

  • Recall Number: Z-1346-2020

REASON

A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could lead to incorrect repositioning of the patient and dose to wrong location.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc on 1/16/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

64 Worldwide/26 Domestic

DISTRIBUTION

US Nationwide and International

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.