Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 6/6/2022
Class II
PRODUCT
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
Recall Number:
Z-1243-2022
REASON
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc. on 4/13/2022. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
443
DISTRIBUTION
Domestic distribution nationwide.
