Recalls / —
—#50463
Product
AXIOM Artis MP, Angiographic x-ray system, model number 7555365
- FDA product code
- IZI — System, X-Ray, Angiographic
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K010721
- Affected lot / code info
- Model number 7555365 - serial numbers 57004, 57008, 57009, 57012, 57045, 57016, 57024 and 57041
Why it was recalled
C-arm gantry could rapidly descend without command during use
Root cause (FDA determination)
Other
Action the firm took
In response to this issue, a Siemens Service Representative will visit the affected consignees beginning 02/01/2007, to check the spindle and adjust the spindle, if necessary.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406
Distribution
- Distribution pattern
- The products were shipped to medical facilities nationwide.
Timeline
- Recall initiated
- 2007-01-31
- Posted by FDA
- 2007-03-08
- Terminated
- 2009-05-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #50463. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.