Recall Z-0128-2009 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392.
| Date | Nov 25, 2008 (initiated Sep 2, 2008) |
| Status | Terminated |
| Reason | Incorrect contour finding: Image may be calibrated to the wrong size catheter. |
| Root cause | Software design |
| Action | Siemens issued a Customer Safety Advisory Notice dated 8/29/08 to inform customers of the potential issue. The recalling firm issued Update Instructions AX040/08/S to the service engineers which provides information to fix the problem. |
| Quantity | 46 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |