Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
This recall has been terminated (originally issued December 24, 2015).
- Recall Initiated
- October 30, 2015
- Posted
- December 24, 2015
- Terminated
- March 28, 2017
- Recall Number
- Z-0481-2016
- Quantity
- 17
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only sporadic cases have been observed in factory screening.
Distribution
US Distribution to the states of : IL, WI, MA, FL, AL, TN, ND, OH, TX, CA, NJ and MI.
Lot / Code Info
Model numbers 10094135, 10094137, 10094141, 10848280, 10848281, 10848282, 10848355. Serial Numbers 123026, 147909, 123031, 103030, 147912, 147910, 147921, 147919, 131005, 121096, 125004, 137551, 121088, 109104, 109105, 109107, and 121085.
Root Cause
Software design
Action Taken
Siemens sent an Important Customer Safety Notice dated October 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The issue will be remedied with a hardware update AX025/15/S. The affected bypass module hardware will be exchanged with unaffected production lots to eliminate the problem. For further questions call: (610) 219-6300.