FDA recall Z-0474-2022

Siemens Medical Solutions USA, Inc · Class II · device

Product

SOMATOM Edge Plus-Computed tomography system Model 1026700

Reason for recall

Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2021-11-19
Report date
2022-01-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0474-2022