Recalls / —
—#38293
Product
Axiom Artis MP X-Ray System
- FDA product code
- IZI — System, X-Ray, Angiographic
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K010721
- Affected lot / code info
- Serial numbers 10, 1021, 1025, 1026, 1027, 1043, 1044, 1048, 1050, 1052, 1056, 1065, 1067, 1069, 1080, 1082, 1083, 1085, 1087, 1089, and 1097.
Why it was recalled
potential problem with the fluoroscopy switch on the power grip
Root cause (FDA determination)
Other
Action the firm took
The recalling firm''s Customer Service Engineers are visiting each account to correct/replace the Power Grip button.
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 hospitals in AL, AZ, DC, DE, IA, MI, NC, NE, PA, RI, TX, WA, and WI.
Timeline
- Recall initiated
- 2005-04-01
- Posted by FDA
- 2005-05-11
- Terminated
- 2005-08-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #38293. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.