CLASS II ONGOING Device recall · Reported 30 Apr 2025 · FDA Enforcement Report
Veradius Unity recalled by Philips North America
Philips North America is recalling Veradius Unity. The recall was initiated on 25 Feb 2025 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-1582-2025
- FDA event ID
- 96593
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Feb 2025
- FDA classified
- 21 Apr 2025
- Reported
- 30 Apr 2025
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 25 Feb 2025 | Recall initiated by company | |
| 21 Apr 2025 | Classified by FDA | +55 days |
| 30 Apr 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
Product as listed by the FDA
Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
Where it was distributed
US
Questions about this recall
Why was it recalled?
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
Which lots are affected?
Product UDI: (01)00884838058194(21) 459801442981, Wireless foot switch set 3P (WFSS 3P) 459801238231, Wireless foot switch 3P, 459801257861, WFS Base Station 459800627394, Wireless foot switch set 3P 459800415535, Wireless foot switch 3P, 459800415542, WFS Base Station
Where was it sold?
US
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
2 other products · FDA event 96593This product is part of a recall event; the main page for the event is Zenition 70. Product Code 718133. The devices are used recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Zenition 70. Product Code 718133. The devices are used recalled | Philips North America | Other | MA | |
| CLASS II | Zenition 50. Product Code 718096. The devices are used recalled | Philips North America | Other | MA |
More recalls from Philips North America
All 545| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Ingenia Ambition S and Ingenia Ambition recalled | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T recalled | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Ingenia 3.0T and Ingenia 3.0T CX recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
Other Surgical Instruments recalls
All 3,816| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled | Stryker Sustainability Solutions | Device Malfunction | Nationwide |
| Device | CLASS II | Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical | Wilson-Cook Medical | Device Malfunction | Nationwide |
| Device | CLASS II | REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability | Stryker Sustainability Solutions | Device Malfunction | Nationwide |