Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimal
Check against the official notice below — it lists the full affected range.
Philips Medical Systems is recalling foot switches used with certain medical imaging equipment because the pedals may bend if used frequently on non-flat surfaces or in the pedestal. When bent, these foot switches may cause the equipment to intermittently or completely fail to produce live fluoroscopy images or exposures. The recall affects approximately 7,209 units distributed nationwide, primarily in California, Florida, Michigan, Oregon, Pennsylvania, Texas, and Washington.
The affected foot switches are identified by multiple product codes, including both wired and wireless models designated as CV 3p 4m, MD 3p 6m, CV 3p 8m, and CV 4p+2 variants. The source document does not specify what remedy an affected consumer should take.
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.