Recall – X-ray software incorrectly interprets table rotation

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 11/10/2021
Class II

PRODUCT

Artis zeego, Fluoroscopic X-Ray System:

  • Models: 10280959,10502505, 10848283

in combination with the following workplace/system application software models:

  • Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815

Recall Number: Z-0200-2022

REASON

Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than four degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc. on 9/24/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

43 US

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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