Recall Z-2478-2018— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-02-01, terminated 2020-05-01. FDA's recall record names no specific 510(k) clearance for this event. Product: SOMATOM Spirit(Model 10045692 ). Reason: A potential risk of unnecessary radiation exposure due to a software issue.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-01
- Terminated
- 2020-05-01
- Firm location
- Malvern, PA, United States
Product description
SOMATOM Spirit(Model 10045692 )
Reason for recall
A potential risk of unnecessary radiation exposure due to a software issue
Data sourced from openFDA. This site is unofficial and independent of the FDA.