Recall Z-2478-2018 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Spirit(Model 10045692 )
| Date | Mar 30, 2018 (initiated Feb 1, 2018) |
| Status | Terminated |
| Reason | A potential risk of unnecessary radiation exposure due to a software issue |
| Root cause | Software design |
| Action | Customers were sent notification letter via USPS with Certified Mail Receipts and Electronic Receipts. |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.