AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and bipla
FDA device recall Z-1272-2014 · posted 2014-03-22 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the gantry system.
- Action taken
- Siemens sent a recall notification letter, dated February 7, 2014, to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions call +49 9191 18 0.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 37
- Distribution
- USA Nationwide Distribution in the states of WI, KY, OH, NJ, NC, FL, PA, MA, IA, TX, NY, IL, MI, AZ, CA, and LA.
- Date initiated
- 2014-02-07
- Date posted
- 2014-03-22
- Date terminated
- 2014-12-30
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS ZEE AND ZEEGO (K073290) | Siemens Medical Solutions USA, Inc. | 2008-02-11 |