Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 1/19/2022
Class II
PRODUCT
SOMATOM Confidence – Computed tomography systems
Model: 10590100
Recall Number: Z-0472-2022
SOMATOM Definition AS-Computed tomography system
Model 8098027
Recall Number: Z-0473-2022
SOMATOM Edge Plus-Computed tomography system
Model 1026700
Recall Number: Z-0474-2022
SOMATOM Definition Edge -Computed tomography system
Model 10590000
Recall Number: Z-0475-2022
REASON
Software version VB20_SP5 may lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc. on 11/19/2021. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
108 units
DISTRIBUTION
U.S. Nationwide