PlainRecalls
FDA Devices Moderate Class II Terminated

SOMATOM Force with software syngo.CT VB20 Model #10742326

Reported: December 1, 2021 Initiated: August 30, 2021 #Z-0283-2022

Product Description

SOMATOM Force with software syngo.CT VB20 Model #10742326

Reason for Recall

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

Details

Units Affected
232 units
Distribution
US Nationwide distribution.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
SOMATOM Force with software syngo.CT VB20 Model #10742326. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 232 units.
Why was this product recalled?
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur
Which agency issued this recall?
This recall was issued by the FDA Devices on December 1, 2021. Severity: Moderate. Recall number: Z-0283-2022.