FDA Device recall Z-2485-2023
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
- FDA Device
- Class II
- ongoing
- Published 2023-09-06
On 2023-09-06 the FDA classified a Class II recall of Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems by Philips Medical Systems Nederland B V, citing loss of availability of the wireless foot switch during procedures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2485-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-30 |
| Published | 2023-09-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Reason
Loss of availability of the wireless foot switch during procedures.
Identifiers
| code_info | Model No.: 722001, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722023, 722025, 722026, 7220…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2485-2023%22
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