Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1141-2019 — Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper FD10/10 722006 Allura Xper FD20 722008 Allura Xper FD20 Biplane 722010 Allura Xper FD10 722011 Allura Xper FD10/10 722012 Allura Xper FD20 72201

U.S. FDA — Device Enforcement · Netherlands · 2019-02-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1141-2019
Date of alert
2019-02-19
Country / jurisdiction
Netherlands
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems Nederlands
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
452270000141
Reported risk: Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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