Recalls / —
—#137942
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.
- FDA product code
- JAK — System, X-Ray, Tomography, Computed
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K133424
- Affected lot / code info
- 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
Why it was recalled
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 (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406
Distribution
- Distribution pattern
- Nationwide Distribution.
Timeline
- Recall initiated
- 2015-06-04
- Posted by FDA
- 2015-06-27
- Terminated
- 2017-03-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #137942. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.