Recall Z-1747-2018 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
| Date | Nov 8, 2017 |
| Status | Terminated |
| Reason | There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force. |
| Root cause | Device Design |
| Action | Siemens Medical Solutions USA, Inc. will bring defect into Compliance noted below: 1.You will contact customers and initiate the actions to correct the failure to comply issue. 2. You will provide a software update to correct tube current calculations by the CARE Dose4D algorithm for head scans. 3.You will follow-up with consignees to verify the effectiveness of the software update. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 |
| Quantity | 238 |
| Distribution | Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, Siemens Medical Solutions USA, Inc., Nov 24, 2015 |