08
Sep
2021

Recall – Angiography system sporadically fails during startup

,
0

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

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