Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0848-04

Axiom Artis System

Siemens Medical Solutions USA, Inc. / initiated 2003-05-28 / Terminated

Siemens Medical Solutions USA, Inc began a recall of Axiom Artis System on . The reason FDA records is "patient images misidentified". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0848-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
Axiom Artis System
Product code
IZI System, X-Ray, Angiographic
Reason for recall
patient images misidentified
FDA root cause
Other
Action
The recalling firm issued recall letters dated 5/28/03 to their accounts informing them of the problem.
Quantity in commerce
46 units
Distribution
The products were shipped to medical facilities nationwide.
Product codes and lots
Part numbers 5904433, 5904649, 5904466, 5904441, 5904656, and 7007755. Serial numbers 10070, 10075, 10076, 10101, 10138, 10148, 10240, 10241, 10248, 10251, 10255, 10257, 10261, 10263, 10266, 14068, 20015, 20129, 20136, 25092, 25112, 25134, 25135, 25148, 25156, 25157, 25159, 25160, 25163, 25169, 25170, 28008, 28015, 28019, 28046, 28047, 28049, 28053, 28058, 28059, 28061, 32004, 32013, 32017, and 32019.