Recall – Angiography system sporadically fails during startup

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

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.

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