FDA recall Z-0286-2022

Siemens Medical Solutions USA, Inc · Class II · device

Product

SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603

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

Distribution

US Nationwide distribution.

Key facts

Status: Terminated
Initiation date: 2021-08-30
Report date: 2021-12-01
Termination date: 2024-01-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0286-2022