FDA Device recall Z-1747-2018
SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
- FDA Device
- Class II
- terminated
- Published 2018-05-23
On 2018-05-23 the FDA classified a Class II recall of SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system by Siemens Medical Solutions Usa, citing 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 SOM….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1747-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-08 |
| Published | 2018-05-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | DC, PR |
Product
SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
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.
Identifiers
| code_info | Serial Numbers: 73917 73064 98602 98603 73476 73339 73739 73059 73586 73421 73937 98616 73312 74206 73075…Serial Numbers: 73917 73064 98602 98603 73476 73339 73739 73059 73586 73421 73937 98616 73312 74206 73075 73099 73544 73648 74156 73734 73343 73374 73726 73526 73636 73346 73518 74207 73258 74054 73860 73579 73813 73930 73120 73108 74360 73054 74128 74926 73679 73427 98600 73622 73533 73621 73423 73424 73493 73520 73718 73459 73372 73637 73303 73296 73349 74924 74927 73786 73240 73279 73278 74374 73531 73760 73831 73224 73820 74042 73840 74191 73832 73152 74117 74118 74405 73673 73651 73352 73044 74456 73487 73492 73494 73497 73016 73711 74929 73310 73409 73778 73935 73642 73709 73722 74240 73130 73013 73657 73300 73499 73535 73090 98607 73377 73031 73355 73777 98617 73330 73883 73366 73783 73036 73623 73908 74978 73667 73285 73281 73141 73684 73248 74391 74209 73490 74399 73461 73428 73791 73455 73191 73887 73071 98606 74094 98601 74098 74045 7436 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1747-2018%22
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