Recall Z-1202-2014 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
| Date | Mar 27, 2014 (initiated Dec 5, 2013) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 19 |
| Distribution | USA Nationwide Distribution in the states of TN, MA, CA, IL, OH, FL, UT, WA, GA, IA, NY, MO, IN, and CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123529 | ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM Siemens Medical Solutions USA, Inc., Feb 26, 2013 |