CLASS II ONGOING Device recall · Reported 6 Sep 2023 · FDA Enforcement Report
Wireless Foot Switch distributed recalled by Philips Medical Systems
Philips Medical Systems Nederland B.v is recalling Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional, distributed nationwide in the US. The recall was initiated on 30 Jun 2023 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-2485-2023
- FDA event ID
- 92782
- Recalling firm
- Philips Medical Systems Nederland B.v, Best, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jun 2023
- FDA classified
- 30 Aug 2023
- Reported
- 6 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 30 Jun 2023 | Recall initiated by company | |
| 30 Aug 2023 | Classified by FDA | +61 days |
| 6 Sep 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Loss of availability of the wireless foot switch during procedures.
Product as listed by the FDA
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Chile, China, Croatia, Czech Republic, Denmark, Egypt, Fiji, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kosovo, Latvia, Lebanon, Libya, Malaysia, Maldives, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, State of, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, and Yemen.
Questions about this recall
Is Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional recalled?
Yes. Philips Medical Systems Nederland B.v recalled Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional on 30 Jun 2023. The recall is Class II and its status is Ongoing. Recall number Z-2485-2023.
Why was it recalled?
Loss of availability of the wireless foot switch during procedures.
Which lots are affected?
Model No.: 722001, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722023, 722025, 722026, 722027, 722028, 722029, 722033, 722035, 722038, 722039, 722058, 722059, 722064, 722065, 722066, 722067, 722068, 722078, 722079; No UDI-DI; Lot No. 459800772231, 459800772233, 459800772261, 459800772263, 459800415531,459800415532, 459800415533, 459800415534, 459800415535, 459800415571, 459800415572, 459800415573, 459800415574, 459800415575.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Chile, China, Croatia, Czech Republic, Denmark, Egypt, Fiji, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kosovo, Latvia, Lebanon, Libya, Malaysia, Maldives, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, State of, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, and Yemen.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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