Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 9/8/2021
Class II
PRODUCT
Artis Models with SW version VD12 listed below:
- Artis zee floor 10094135
- Artis zee ceiling 10094137
- Artis zee MP 10094139
- Artis Q floor 10848280
- Artis Q ceiling 10848281
- Artis Q biplane 10848282
- Artis Q.zen floor 10848353
- Artis Q.zen ceiling 10848354
- Artis Q.zen biplane 10848355
Angiography systems developed for single and biplane diagnostic imaging
Recall Number: Z-2404-2021
REASON
Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc on 6/30/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
70 US (172 WW)
DISTRIBUTION
U.S. Nationwide