—#154246

Product

The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 722003; Allura Xper FD10/10 722005; Allura Xper FD20 722006; Allura Xper FD20/10 and FD20/20 722008; Allura Xper FD10 722010; Allura Xper FD10/10 722011; Allura Xper FD20 722012; Allura Xper FD20 biplane 722013; Allura Xper FD10 OR Table 722014; Allura Xper FD20 OR Table 722015; Allura Xper FD10/10 OR Table 722019; Allura Xper FD20 Biplane OR Table 722020; Allura Xper FD10 OR Table 722022; Allura Xper FD20 OR Table 722023; Allura Xper FD10/10 OR Table 722024; Allura Xper FD20 Biplane OR Table 722025; Allura CV20 722031

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031333, K033737, K041949, K102005
Affected lot / code info: Devices with a Laird Chiller.

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Nationwide, worldwide including Canada

Timeline

Recall initiated: 2017-03-22
Terminated: 2021-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154246. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.