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Open, Classified

Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems

FDA Recall Z-2587-2023 · Posted 2023-09-14

Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2023-08-15
Product Quantity19,115 systems

Reason for Recall

A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.

Firm Action

US customers were notified via certified mail via USPS. OUS customers were notified through the Philips Markets Organizations. Philips is issuing two Urgent Medical Device Correction letters, one for Allura and Azurion customers and another one for MultiDiagnost Eleva Customers. Additionally, an IFU addendum will be provided to customers that includes instructions on how to handle the footswitch cable. For Allura and Azurion customers an updated preventative maintenance manual update is also being provided. Philips will contact customers to schedule a visit to inspect the foot switch and to provide an IFU Addendum.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020-05-01K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017-01-26K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016-12-02K050151MULTIDIAGNOST ELEVAPhilips Medical Systems North America, Inc. · 2005-02-09

Official Source

View FDA Recall →

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

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