FDA recall Z-3025-2020

Siemens Medical Solutions USA, Inc · Class II · device

Product

Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)

Reason for recall

Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2020-06-22
Report date: 2020-10-07
Termination date: 2021-03-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3025-2020