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Open, Classified

BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.

FDA Recall Z-0224-2024 · Posted 2024-09-30

Recalling FirmPhilips North America
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2023-10-04

Reason for Recall

Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

Root Cause

Device Design

Distribution Pattern

United States Territories of Puerto Rico, Guam, and Virgin Islands

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010435PHILIPS BV PULSERA/ENDURAPhilips Medical Systems, Inc. · 2001-03-12

Official Source

View FDA Recall →

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

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