Recall – Angiography system stand movements blocked due to software

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 3/25/2020
Class II

PRODUCT

Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

  • Recall Number: Z-1495-2020

REASON

A software issue could potentially cause the stand and table movements to be blocked.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc on 2/14/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

1452 worldwide (638 US)

DISTRIBUTION

US Nationwide

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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.