FDA Device recall Z-0605-2017
SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS systems are intended to produce cross-sectional i…
- FDA Device
- Class II
- terminated
- Published 2016-11-23
On 2016-11-23 the FDA classified a Class II recall of SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS systems are intended to produce cross-sectional i… by Siemens Medical Solutions Usa, citing A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash sys….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0605-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-19 |
| Published | 2016-11-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
Reason
A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becoming loose or potentially dropping out. There is a risk that a person could touch rotating or electrical parts of the gantry if they were to reach through the window opening.
Identifiers
| code_info | Serial Numbers: 73064 64789 64492 65127 64464 64471 65380 66632 65852 64668 64239 65364 64580 73476 733…Serial Numbers: 73064 64789 64492 65127 64464 64471 65380 66632 65852 64668 64239 65364 64580 73476 73339 64278 64756 73059 64800 64412 65288 64645 64725 73421 64508 65339 65346 64714 65831 64123 64246 65690 65752 64658 73312 66858 65491 66611 64465 65076 64454 65762 64485 64446 64673 66319 64419 66518 65968 66506 66171 66243 73544 64368 64736 65620 64081 64117 64549 65175 65569 64112 66287 66292 64164 64180 66087 65322 65768 65425 65810 73343 73374 65326 64461 65764 66929 65615 66251 66327 66826 64497 66146 64067 64428 65355 66635 66225 65039 64111 65314 64371 66188 66355 66476 64138 73518 65209 66467 64860 66649 66182 73258 64342 73579 64372 66998 66759 64420 65264 66150 64235 65712 66461 66604 73120 66411 64179 65515 66498 73108 64178 66688 66164 64172 66433 66141 64074 66572 66944 64253 65015 66768 64482 64170 66405 64825 64328 65075 65671 64 |
|---|
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-0605-2017%22
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