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Recall Observatory FDA recall evidence

Device product

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

Z-0725-2022

November 24, 2021

Class II

Product summary

Firm
Philips North America Llc
Event
Event 89375
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-0725-2022

Official wording

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.

Code information: S/N: OUS 109

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.)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.