CLASS II Device recall · Reported 24 Apr 2019 · FDA Enforcement Report

Foot Switches used with the following systems recalled

Philips Medical Systems Nederlands is recalling Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura, distributed nationwide in the US. The recall was initiated on 19 Feb 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesFoot 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.

Quantity recalled7209 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1141-2019
FDA event ID: 82459
Recalling firm: Philips Medical Systems Nederlands, Best, N/A
Classification: Class II
Status: Terminated
Recall initiated: 19 Feb 2019
FDA classified: 13 Apr 2019
Reported: 24 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

19 Feb 2019	Recall initiated by company
13 Apr 2019	Classified by FDA	+53 days
24 Apr 2019	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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 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 perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.

Where it was distributed

US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA.

Nationwide California Florida Michigan Oregon Pennsylvania Texas Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 82459

This product is part of a recall event; the main page for the event is Foot Switches used with Philips MultiDiagnost Eleva recalled.

Reported	Class	Recall	Company	Reason	Where
24 Apr 2019	CLASS II	Foot Switches used with Philips MultiDiagnost Eleva recalled	Philips Medical Systems Nederlands	Other	Nationwide

More recalls from Philips Medical Systems Nederlands

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Reported	Class	Recall	Company	Reason	Where
30 Jun 2021Device	CLASS II	Philips Allura Xper System: Interventional Fluoroscopic recalled	Philips Medical Systems Nederlands	Device Malfunction	10 states
7 Aug 2019Device	CLASS II	Azurion lnterventional Fluoroscopic X-ray System recalled	Philips Medical Systems Nederlands	Device Malfunction	Nationwide
8 May 2019Device	CLASS II	Ingenia Ambition S (781359), Ingenia Ambition X recalled	Philips Medical Systems Nederlands	Other	FL
24 Apr 2019Device	CLASS II	Foot Switches used with Philips MultiDiagnost Eleva recalled	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019Device	CLASS II	Intera 1.5T High Performance recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide

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