Axiom Aristos X-Ray System.
FDA Recall Z-0984-03 · Posted 2003-07-08
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeKPR
Date Initiated2003-04-19
Date Terminated2004-08-25
Product Quantity5 units
Reason for Recall
software malfunction. May indicate that the image is flipped when it is not.
Firm Action
The recalling firm issued recall letters dated 4/19/03 to their accounts along with instructions for handling images that have already been archived.
Root Cause
Other
Distribution Pattern
The units were shipped to medical facilities 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.