Recall- Software error may lead to treatment on alternate system

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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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