Medical device recalls Moderate risk

UNIQ: UNIQ FD10 recalled over fire hazard

Recall date
March 22, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Philips Electronics North America Corporation recalls UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ FD10/10 OR Ta…
Recall number
Z-1821-2017
FDA classification
Class II
Brand / firm
Philips Electronics North America Corporation
Sold / distributed
Nationwide, worldwide including Canada

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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