Reported Apr 24, 2019 · Terminated
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The…
Philips Medical Systems Nederlands
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems Nederlands · Veenpluis 4-6 · Best, N/A · N/A
Is this the product you have?
- Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector
- Product Codes708037, 708038 Product The Allura Xper FD Series are intended
- for use on human patients to performVascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures
- Lot codes and dates
- Foot Switches
452270000141 Footswitch CV 3p 4m452270000151 Footswitch MD 3p 6m452270000142 Footswitch CV 3p 4m452270000381 Footswitch CV 3p 8m452270000382 Footswitch CV 3p 8m459800076001 Footswitch CV 4p+2 4m459800076021 Footswitch CV 4p+2 8m459800415571 Wireless Footswitch 4p+2459800415581 Wireless footswitch set 4p+2459800415531 Wireless Footswitch 3P459800415561 Wireless footswitch set 3P
- Foot Switches
- Amount recalled
- 7209 total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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