AXIOM Artis. Angiographic X-ray System.
FDA device recall Z-0193-2009 · posted 2008-11-04 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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 taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 1,530 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-08-22
- Date posted
- 2008-11-04
- Date terminated
- 2009-09-23
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM (K010721) | Siemens Medical Corp. | 2001-03-30 |