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 722013 Allura XPER
Check against the official notice below — it lists the full affected range.
Philips Medical Systems is recalling 7,209 foot switches used with Allura Xper FD 10 fluoroscopy systems due to a hazard identified as part of a previous recall. If a foot switch is frequently used on a non-flat surface or in the pedestal, the pedals may become bent, which could result in an intermittent or continuous inability to make live fluoroscopy images or exposures. The recalled foot switches were distributed nationwide in California, Florida, Michigan, Oregon, Pennsylvania, Texas, and Washington.
The recall affects multiple foot switch models with specific lot codes, including both wired and wireless versions of CV and MD foot switches. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA. Quantity: 7209 total 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.