FDA Device recall Z-0473-2022
SOMATOM Definition AS-Computed tomography system Model 8098027
- FDA Device
- Class II
- ongoing
- Published 2022-01-19
On 2022-01-19 the FDA classified a Class II recall of SOMATOM Definition AS-Computed tomography system Model 8098027 by Siemens Medical Solutions Usa, citing software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0473-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-19 |
| Published | 2022-01-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
SOMATOM Definition AS-Computed tomography system Model 8098027
Reason
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Identifiers
| code_info | Serial Numbers: 96278 96887 66027 64492 64541 64519 64427 67297 95303 96267 64864 96211 59802 67241 64798 98423 65597 9…Serial Numbers: 96278 96887 66027 64492 64541 64519 64427 67297 95303 96267 64864 96211 59802 67241 64798 98423 65597 95389 96689 64419 64347 64860 64382 64869 65238 66734 92078 95804 96471 98402 95985 96710 95889 95778 92353 95847 95936 67236 64464 64471 65852 95798 96454 96466 95363 64927 91966 98354 95934 96279 95807 95602 95639 65288 64773 95229 65297 65159 64036 95628 66143 64317 95610 98474 95859 95939 95601 95070 95882 95596 95791 66219 65752 98356 95677 64104 66506 66312 95844 95670 66858 65382 98424 66588 92280 67399 64413 64559 64235 66611 92056 92261 92342 95684 66319 95545 96547 95702 95766 67218 67128 64859 95788 64487 96491 65370 95234 95466 95809 67098 95616 59819 66032 95372 95461 95043 66087 95582 95143 67363 96950 65768 92186 96941 95951 95100 98422 98413 66600 64030 66844 66649 66635 95299 66225 66842 66916 95584 95151 66188 66355 64022 92375 95578 96777 66467 98417 64498 64763 64372 95362 65788 65015 66150 96647 66933 96472 98366 65299 66461 66604 65115 66441 96948 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0473-2022%22
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