Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
FDA device recall Z-2108-2013 · posted 2013-08-28 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used.
- Action taken
- Siemens sent Update Instructions dated December 2012, to all affected customers. This update was initiated on behalf of the US service organization to re-check all systems installed by MEC Group. A call center representative or designated engineer called each site on April 26, 2013, and described the work being done, amount of time needed and number of engineers that would be on site. At that time the call center or engineer scheduled the update with the customer. For further questions please call (610) 219-6300.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 178
- Distribution
- US Distribution including the states of PA, NJ, DC, VA, MD and DE.
- Date initiated
- 2013-04-26
- Date posted
- 2013-08-28
- Date terminated
- 2014-11-06
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS (K021021) | Siemens Medical Solutions USA, Inc. | 2002-06-06 |