SOMATOM Definition Flash — Class II medical device recall Z-1747-2018
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2018-05-23, distributed in DC, GU, PR. There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D a
| Recall number | Z-1747-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2017-11-08 |
| Classified | 2018-05-15 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2023-05-18 |
| Distributed | DC, GU, PR |
| Quantity | 238 |
| Reason classes | software |
| Serial numbers | 73013, 73016, 73028, 73030, 73031, 73035, 73036, 73044, 73054, 73059, 73061, 73064, 73071, 73075, 73090, 73099, 73108, 73120, 73122, 73127, 73130, 73141, 73151, 73152, 73153 and 213 more |
| Model numbers | 10430603 |
Product
SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1747-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.