Recalls / —
—#73323
Product
BICOR HS X-Ray System, Model number 6005776
- FDA product code
- IZI — System, X-Ray, Angiographic
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K940484
- Affected lot / code info
- Model number 6005776 - Serial numbers: 3016 and 3026
Why it was recalled
Unintended movement of the system table and/or C arm.
Root cause (FDA determination)
Software design
Action the firm took
Siemens Medical Solutions issued a letter to consignees on 8/11/2008 to inform them of the problem and a workaround should the issue occur prior to software revision.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2008-08-11
- Posted by FDA
- 2008-11-04
- Terminated
- 2012-12-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #73323. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.