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Z-0725-2022 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

FDA device recall Z-0725-2022 was initiated by Philips North America Llc on November 24, 2021 and is designated Class II. Reason for recall: 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 th… The recall status is ongoing. Affected quantity: 1 unit.

Recall Details

Product Type: Devices
Report Date: March 16, 2022
Initiation Date: November 24, 2021
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1 unit

Product Description

Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031

Reason for Recall

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.

Distribution Pattern

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 Thailand Turkey United Kingdom Virgin Islands (U.S.)

Code Information

S/N: OUS 109

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