Recall Z-0724-2022 ยท OWB Interventional Fluoroscopic X-Ray System
Philips North America Llc
Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722029, 722033, 722034, 722036, 722038, 722039. Allura Xper F010 {C+F). 722003 Allura
| Date | Nov 24, 2021 |
| Status | Open, Classified |
| Reason | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire. |
| Root cause | Process control |
| Action | Philips Issued Medical Device Correction letter dated 11/24/21 to U.S.A, Customers via certified mailing from the United States Postal Service (USPS). Letters outside of the U.S.A. will be distributed through the Philips Markets Organizations. Letter states reason for recall, health risk and action to take: Philips will inspect the affected systems for leaks and repair as required. In addition, Philips will install an extended drip tray to prevent damage from any future leaks. This service will be provided free of charge for affected systems. A Philips service representative will contact custo |
| Quantity | USA: 63 systems R.O.W.: 127 systems |
| Distribution | US Nationwide Foreign: Argentina Austria Bangladesh Brazil Chile China Denmark Dominican Republic France Germany Greece India Indonesia Iran Israel Italy Japan Korea, Republic of Malaysia Mexico Netherlands Philippines Russian Federation Saudi Arabia South Africa Spain Sri Lanka Switzerland Taiwan T |
| FDA record | Open on fda.gov |