Axiom Artis systems, dedicated angiography systems developed for single and biplane diagnostic imaging and interventiona
FDA device recall Z-2342-2015 · posted 2015-08-05 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.
- Action taken
- A customer safety notice, dated June 29, 2015, was sent to direct accounts to alert them about the issue and that Siemens' service organization will be contacting them to perform the corrective action.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IZI
- Distribution
- US Nationwide
- Date initiated
- 2015-06-29
- Date posted
- 2015-08-05
- Date terminated
- 2016-12-07
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM (K010721) | Siemens Medical Corp. | 2001-03-30 |