FDA-Device2019-04-24Class II
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 minimally invasive procedures.
Philips Medical Systems Nederlands
Hazard
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.
Sold states
US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA.
Affected count
7209 total
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Products
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 minimally invasive procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1140-2019Don't want to check this manually?
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