FDA Device recall Z-1745-2018
SOMATOM Definition AS (Model 8098027) 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 AS (Model 8098027) 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-1745-2018 |
| 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 AS (Model 8098027) 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: 96278 64789 64492 64541 65127 95804 98402 96795 64689 65442 64464 64471 96608 96666 65380…Serial Numbers: 96278 64789 64492 64541 65127 95804 98402 96795 64689 65442 64464 64471 96608 96666 65380 67102 66632 66767 65852 64870 64668 95258 96710 95889 67127 64239 65364 96428 64580 95798 96466 96649 98361 67120 95363 64278 64756 64800 64412 98354 95934 96279 65288 95054 96698 96479 64645 64725 95985 95229 64508 95854 98365 96379 95628 65339 65346 64714 95610 95939 95601 65831 65868 95596 95882 95791 64123 64246 65558 95859 65690 66219 64059 65752 98356 95677 95844 64658 95600 95670 66858 65491 96753 98424 67399 66611 64465 65076 95084 95998 64841 64454 95098 65762 95311 95604 96602 64485 64446 95684 64673 66319 95545 96547 95319 64419 95702 66518 65968 95332 95766 66168 65453 95650 96628 67218 67128 66640 66506 66312 64487 95788 95375 95234 95466 95809 64368 59818 64759 67098 98355 95616 95641 64477 64736 59819 64081 64117 64549 65175 6556 |
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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-1745-2018%22
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