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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

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