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Recall Observatory FDA recall evidence

Device product

UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ FD10/10 OR Table 722034; UNIQ FD20/10 OR Table 722036; UNIQ FD20/20 722038; UNIQ FD20/20 biplane OR Table 722039

Z-1821-2017

March 22, 2017

Class II

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 76810
Status
Terminated
Classification
Class II
Quantity
6992 (total for all devices)
Official record key
device-enforcement:Z-1821-2017

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: Devices with a Laird Chiller.

Distribution pattern: Nationwide, worldwide including Canada

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.