Axiom Artis System, X-ray, Angiographic
This recall has been terminated (originally issued December 18, 2002).
- Company
- Siemens Medical Systems Inc
- Recall Initiated
- August 5, 2002
- Posted
- December 18, 2002
- Terminated
- October 25, 2004
- Recall Number
- Z-0347-03
- Quantity
- 134
- Firm Location
- So Iselin, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Set delay time for contrast injection exceeds 10 seconds, radiation release button is blocked.
Distribution
The device was distributed to Hospitals nationwide.
Lot / Code Info
Axiom Artis System: Axiom Artis FC Model #5904433 --all serial #s Axiom Artis FA Model #5904441 --all serial #s Axiom Artis BC Model #5904649 --all serial #s Axiom Artis BA Model #5904656 --all serial #s Axiom Artis MP Model #5904466 -- all serial #s
Root Cause
Other
Action Taken
A Safety Advisory Letter was sent 7/23/2002 by Siemens Medical. The letter advised the technicians of the problem and Siemens would be coming out to do the software modificaitons.