Recalls / —
—#138061
Product
SOMATOM Emotion 6; 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: 10165888 with serial numbers: 29161 29185 29186 29165 29176 29181 29198
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 #138061. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.