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Terminated

Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD10/10 722027; Allura Xper FD20/10 biplane 722029; Allura Xper FD10 OR Table 722033; Allura Xper FD10/10 OR Table 722034; Allura Xper FD20/10 OR Table 722036; Allure Xper FD20/20 722038; Allura Xper FD20/20 biplane OR Table 722039

FDA Recall Z-1820-2017 · Posted None

Recall StatusTerminated
Product CodeOWB
Date Initiated2017-03-22
Date Terminated2021-05-17
Product Quantity6992 (total for all devices)

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.

Firm Action

Consignees were notified of the recall via letter sent on 3/22/2017. The letter explains the issue, actions that should be taken by the customer, and actions to be taken by Philips.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide, worldwide including Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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