FDA recall Z-0372-2019
Siemens Medical Solutions USA, Inc. · Class II · device
Product
EVO Excel, Emission Computed Tomographic System, Material Number 10910501
Reason for recall
The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A.,
Distribution
Worldwide
Key facts
- Status
- Terminated
- Initiation date
- 2018-10-05
- Report date
- 2018-11-07
- Termination date
- 2021-02-11
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Hoffman Estates, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0372-2019