FDA recall Z-0771-2021

Siemens Medical Solutions USA, Inc · Class II · device

Product

SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus

Reason for recall

System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan

Distribution

US Nationwide

Key facts

Status: Terminated
Initiation date: 2020-11-24
Report date: 2021-01-20
Termination date: 2024-02-06
Voluntary/Mandated: FDA Mandated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0771-2021