Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
This recall has been terminated (originally issued March 27, 2014).
- Recall Initiated
- December 5, 2013
- Posted
- March 27, 2014
- Terminated
- November 6, 2014
- Recall Number
- Z-1202-2014
- Quantity
- 19
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
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).
Distribution
USA Nationwide Distribution in the states of TN, MA, CA, IL, OH, FL, UT, WA, GA, IA, NY, MO, IN, and CO.
Lot / Code Info
model numbers 10848280, 10848281, 10848282, and 10848283.
Root Cause
Device Design
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.