FDA recall Z-2475-2018
Siemens Medical Solutions USA, Inc · Class II · device
Product
SOMATOM Perspective 16 (Model 10891666)
Reason for recall
A potential risk of unnecessary radiation exposure due to a software issue
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2018-02-01
- Report date
- 2018-08-08
- Termination date
- 2020-05-01
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Malvern, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2475-2018