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Open, Classified

MultiDiagnost-Eleva

FDA Recall Z-2404-2023 · Posted 2023-09-07

Recalling FirmPhilips Medical Systems Nederland B.V.
Recall StatusOpen, Classified
Product CodeKPR
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.

K050151MULTIDIAGNOST ELEVAPhilips Medical Systems North America, Inc. · 2005-02-09K023441PHILIPS MULTIDIAGNOST ELEVAPhilips Medical Systems · 2002-10-30

Official Source

View FDA Recall →

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

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