Z-2485-2023Class II

Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray...

Name: Z-2485-2023 Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray...
Creator: Philips Medical Systems Nederland B.v.
Published: 2023-06-30
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2023-06-30 / Open, Classified

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems on 2023-06-30. FDA classified it as Class II and gives the reason as "Loss of availability of the wireless foot switch during procedures". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2485-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-30
Posted: 2023-08-30
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Loss of availability of the wireless foot switch during procedures.
FDA root cause: Under Investigation by firm
Action: Customers were sent an URGENT Medical Device Correction letter dated 6/23/2023 via USPS Certified Mail. Customers are instructed to ensure that the wired footswitch is always connected to the system in case the wireless foot switch becomes unavailable. Customers are instructed to download a copy of the addendum to the IFU for the wireless foot switch and the Quick Reference Card at Http://philips.com/doc_library, and distribute these materials to those who use the system and retain a copy with the system's IFU. These documents are to be placed in an area where they are likely to be seen/viewed with system documentation. Customers are to return the attached response form to Philips no later than 30 days from receipt of the notification to [email protected]. Philips will contact customers to schedule a Field Service Engineer visit to confirm that the wired foot switch is connected to affected systems, perform a check of the charger, and provide customers with a hardcopy of the addendum. Customers with questions can contact Philips Technical Support Line at 1-800-722-9377.
Quantity in commerce: 1865 units
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2485-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2485-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-30

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)