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Open, Classified

Allura Xper series

FDA Recall Z-2402-2023 · Posted 2023-09-07

Recalling FirmPhilips Medical Systems Nederland B.V.
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2023-07-19
Product Quantity5432 systems in total

Reason for Recall

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

Firm Action

Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide actions that should be taken by the customer/user in order to prevent risks to patients. Philips will contact customers to schedule a visit to inspect the foot switch and provide an addendum to the Instructions for Use (IFU) of the system detailing the appropriate cleaning and maintenance instructions. (Philips reference 2023-IGT-BST-011).

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016-12-02

Official Source

View FDA Recall →

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

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