Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
FDA device recall Z-1202-2014 · posted 2014-03-27 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40).
- Action taken
- Siemens sent an Important Customer Safety Notice letter dated November 22, 2013, to affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to discontinue use until the affected product has been successfully replaced by a Siemen's representative.at no cost.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 19
- Distribution
- USA Nationwide Distribution in the states of TN, MA, CA, IL, OH, FL, UT, WA, GA, IA, NY, MO, IN, and CO.
- Date initiated
- 2013-12-05
- Date posted
- 2014-03-27
- Date terminated
- 2014-11-06
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM (K123529) | Siemens Medical Solutions USA, Inc. | 2013-02-26 |