Recall Z-0193-2009 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
AXIOM Artis. Angiographic X-ray System.
| Date | Nov 4, 2008 (initiated Aug 22, 2008) |
| Status | Terminated |
| Reason | Patients could possibly fall off the table if not properly secured when: 1) moving them onto the patient table, 2) moving them on the patient table or 3) removing them from the patient table. |
| Root cause | Labeling design |
| Action | The recalling firm issued a Customer Safety Advisory Notice dated 7/04/08 (including an Addendum to the Operators Manual) which alerts the operator of possible injury to patients if they are not properly secured to the table during examinations and describes the recommended fastening procedures required to properly secure the patient to the table. For questions or additional information, contact Siemens Medical Solutions, Inc. at 610-448-4634. |
| Quantity | 1,530 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010721 | AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM Siemens Medical Corp., Mar 30, 2001 |