Reported Apr 24, 2019 · Terminated
Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper…
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 the following systems722001 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 FD20 BIPLANE 722014 Allura Xper FD10 OR Table 722015 Allura Xper FD20 OR Table 722019 Allura Xper FD10/10 OR Table 722020 Allura Xper FD20 Biplane OR Table 722022 Allura Xper FD10 OR Table 722023 Allura Xper FD20 OR Table 722024 Allura Xper FD10/10 OR Table 722025 Allura Xper FD20 Biplane OR Table 722026 Allura Xper FD10 722027 Allura Xper FD10/10 722028 Allura Xper FD20 722029 Allura Xper FD20/10 722031 Allura CV20 722033 Allura Xper FD10 OR Table 722034 Allura Xper FD10/10 OR Table 722035 Allura Xper FD20 OR Table 722036 Allura Xper FD20/10 OR Table 722038 Allura Xper FD20/20 722039 Allura Xper FD20/20 OR Table 722058 Allura Xper FD20/15 722059 Allura Xper FD20/15 OR Table 722123 Field extensions Xper cardio 722124 Field extensions Xper vascular 722126 SmartPath to upgrade Allura to AlluraClarity cardio 722127 SmartPath to upgrade Allura to AlluraClarity vascular 722133 Field ext. Xper cardio systems R7.6 722134 Field ext. Xper vascular systems 722400 Cardio Vascular-Allura Centron 722030 INTEGRIS CV 722043 INTEGRIS Allura 15-12 (mono) 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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