Axiom Aristos X-Ray System.
FDA device recall Z-0984-03 · posted 2003-07-08 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- software malfunction. May indicate that the image is flipped when it is not.
- Action taken
- The recalling firm issued recall letters dated 4/19/03 to their accounts along with instructions for handling images that have already been archived.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 5 units
- Distribution
- The units were shipped to medical facilities nationwide.
- Date initiated
- 2003-04-19
- Date posted
- 2003-07-08
- Date terminated
- 2004-08-25
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) (K013826) | Siemens Medical Systems, Inc. | 2002-02-01 |