FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
- Recall number
- Z-1933-2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
- Status
- Terminated
- Initiated
- 2015-06-04
- Posted
- 2015-06-27
- Terminated
- 2017-03-24
- Reason
- A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.
- Root cause
- Device Design
- Action
- A safety advisory notice, dated June 4, 2015, was sent to direct accounts explaining the problem and potential risk to patients and operators. Siemens engineers will begin replacing the bolts in May 2015.
- Quantity
- 40 total
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- model numbers: 10165977, with serial numbers: 32310 32254 32322 32317 32303 32295 32327 32309 32319 32237 32326 32259 32323 32257 32298 32315 32268 32244 32252 32293 32349 32313 32334 32301 32339 32277 32292 32281 32273 32320 32324 32346 32270
- 510(k) numbers
- ["K133424"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28