FDA Recall
Terminated
Axiom Artis Zee. Angiographic X-ray System.
Recall: Z-0194-2009
·
Initiated August 22, 2008
Recall
- Recall Number
- Z-0194-2009
- Event Number
- 49529
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- IZI
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- August 22, 2008
- Posted
- November 4, 2008
- Terminated
- September 23, 2009
- Address
- 51 Valley Stream Pkwy, Malvern, PA, 19355
Description
Axiom Artis Zee. Angiographic X-ray System.
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.
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.
Distribution
Nationwide Distribution.
Quantity
108 units