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