CLASS II Device recall · Reported 24 Apr 2019 · FDA Enforcement Report
Foot Switches used with Philips MultiDiagnost Eleva recalled
Philips Medical Systems Nederlands is recalling Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector, 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
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-1140-2019
- 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 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.
Where it was distributed
US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA.
Nationwide CaliforniaFloridaMichiganOregonPennsylvaniaTexasWashington
Questions about this recall
Why was it 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.
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Foot Switches used with the following systems recalled | Philips Medical Systems Nederlands | Other | Nationwide |
More recalls from Philips Medical Systems Nederlands
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Allura Xper System: Interventional Fluoroscopic recalled | Philips Medical Systems Nederlands | Device Malfunction | 10 states |
| Device | CLASS II | Azurion lnterventional Fluoroscopic X-ray System recalled | Philips Medical Systems Nederlands | Device Malfunction | Nationwide |
| Device | CLASS II | Ingenia Ambition S (781359), Ingenia Ambition X recalled | Philips Medical Systems Nederlands | Other | FL |
| Device | CLASS II | Foot Switches used with the following systems recalled | Philips Medical Systems Nederlands | Other | Nationwide |
| Device | CLASS II | Intera 1.5T High Performance recalled by Philips Medical Systems | Philips Medical Systems Nederlands | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,227| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NaviFlex LW Pusher recalled by Boston Scientific | Boston Scientific | Other | Nationwide |
| Device | CLASS II | JenaValve Trilogy Delivery Catheter, Size recalled | Jenavalve Technology | Other | Nationwide |
| Device | CLASS II | Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack recalled | Sarnova HC | Other | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | JenaValve Trilogy Delivery Catheter, Size recalled | Jenavalve Technology | Other | Nationwide |