Philips Medical Systems, Inc.: Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xp

Is my product affected?

Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper FD2O, 722008 Allura Xper FD2O Biplane, 722010 Allura Xper FD1O, 722011 Allura Xper FD1O/10, 722012 A

• UPC 452270000141
• UPC 452270000151
• UPC 452270000142
• UPC 452270000381
• UPC 452270000382
• UPC 459800076001
• UPC 459800076021
• UPC 459800415571
• UPC 459800415581
• UPC 459800415531
• UPC 459800415561

Check against the official notice below — it lists the full affected range.

What happened

Philips Medical Systems, Inc. is recalling foot switches used with Philips Allura Xper imaging systems due to a hazard in which a bent pedal on the foot switch can cause loss of key image functionality. Approximately 4,180 devices are affected across multiple lot and code numbers, including both wired and wireless foot switch models, and the recalled products have been distributed worldwide including throughout the United States and internationally.

The source document does not specify a remedy or what affected consumers should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Loss of key image functionality due to a bent pedal of the Footswitch.

Details from the source

Reason for recall: Loss of key image functionality due to a bent pedal of the Footswitch. Distribution: Worldwide Distribution - US (nationwide) and Internationally to: CZECH REPUBLIC ALBANIA ALGERIA ARGENTINA AUSTRALIA AUSTRIA AZARBAIJAN BAHAMAS BANGLADESH BELGIUM BRAZIL BULGARIA CAYMAN ISLANDS CHILE CHINA COLUMBIA COSTA RICA CROATIA CUBA CZECHOSLOVAKIA DENMARK DOMINICAN REPUB ECUADOR EGYPT ESTONIA FINLAND FRANCE GABON GERMANY GREECE HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN IRAQ IRELAND ISRAE Quantity: 4180 devices Lot/code info: Foot Switches: 452270000141 Footswitch CV 3p 4m; 452270000151 Footswitch MD 3p 6m; 452270000142 Footswitch CV 3p 4m; 452270000381 Footswitch CV 3p 8m; 452270000382 Footswitch CV 3p 8m; 459800076001 Footswitch CV 4p+2 4m; 459800076021 Footswitch CV 4p+2 8m; 459800415571 Wireless Footswitch 4p+2; 459800415581 Wireless footswitch set 4p+2; 459800415531 Wireless Footswitch 3P; 459800415561 Wireless footswitch set 3P.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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