Recall Z-2342-2015 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Axiom Artis systems, dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
| Date | Aug 5, 2015 (initiated Jun 29, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010721 | AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM Siemens Medical Corp., Mar 30, 2001 |