Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allu

FDA device recall Z-0558-2024 · posted 2023-12-15 · Open, Classified

Recall details

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Reason for recall

Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose

Action taken

Philips issued Urgent Medical Device Correction (UMDC) letter US customers in the US on 11/3/23 and a Field Safety Notice (FSN) to customers outside the US. Letter states reason for recall, health risk and action to take: As a remedy, Philips is replacing the existing covers of all the affected Philips Allura and Philips Azurion with the monoplane fixed ceiling mounted systems with a redesigned L-arm rotation cover (bolted instead of spring clips) to make sure it is resistant to external collisions. Philips will contact all affected customers to arrange for a Field Service Engineer visit to replace the Larm rotation cover free of charge (reference FCO72200510 for the Philips Allura systems including the Philips Poly G H5000, FCO72200511 for the Philips Azurion systems). If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).

Root cause

Device Design

Status

Open, Classified

Product code

OWB

Quantity affected

9991 units

Distribution

Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, CA

Date initiated

2023-11-03

Date posted

2023-12-15

Location

Best, Netherlands

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