Recall Z-1589-2018 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Electronics North America Corporation
Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, eg peripheral, cerebral, thor
| Date | Mar 14, 2018 |
| Status | Terminated |
| Reason | After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself. |
| Root cause | Software design |
| Action | Field Safety Notices were distributed on 3/14/18. The notices instructed customers: To prevent occurrence of the issue customers shall restart the system at least once a day. Customer shall ensure that all staff with access to the affected systems are informed of the contents of this Field Safety Notice. A copy of this Field Safety Notice shall be placed together with the documentation of the system until the system has been corrected by Philips. The problems will be resolved by a software update, which is expected to be available by the second half of 2018. You will be notified by you |
| Quantity | 682 |
| Distribution | Worldwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The product was distributed to the following countries: Argentina, Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133292 | ALLURA XPER FD; OR TABLE Philips Medical Systems Nederland B.V., Mar 5, 2014 |