Recall Z-0481-2016 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
| Date | Dec 24, 2015 (initiated Oct 30, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 17 |
| Distribution | US Distribution to the states of : IL, WI, MA, FL, AL, TN, ND, OH, TX, CA, NJ and MI. |
| FDA record | Open on fda.gov |