Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031
Recall
- Recall Number
- Z-0725-2022
- Event Number
- 89375
- Firm
- Philips North America Llc
- FEI Number
- 3016618143
- Product Code
- OWB
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- November 24, 2021
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2289
Description
Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031
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.
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 customers with affected devices to arrange for the service. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377 (reference FCC 72200484).
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1 unit