Axiom Artis System, X-ray, Angiographic
FDA Recall Z-0347-03 · Posted 2002-12-18
Recalling FirmSiemens Medical Systems Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2002-08-05
Date Terminated2004-10-25
Product Quantity134
Reason for Recall
Set delay time for contrast injection exceeds 10 seconds, radiation release button is blocked.
Firm Action
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.
Root Cause
Other
Distribution Pattern
The device was distributed to Hospitals nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.