Recall – Software error results in unavailable measurement

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 1/26/2022
Class II

PRODUCT

1. Sensis, material # 10764561;

UDI : 04056869010137

2. Sensis Vibe Hemo, material # 11007641;

UDI: 04056869010199

3. Sensis Vibe Combo, material # 11007642;

UDI: 04056869010205

Recall Number: Z-0515-2022

REASON

Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain sporadic circumstances, the CO (Cardiac Output) measurement using the Thermodilution method will temporarily no longer be possible.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc. on 11/23/2021. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

1047

DISTRIBUTION

U.S. Nationwide

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Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.