CLASS II Device recall · Reported 22 Sep 2021 · FDA Enforcement Report
The Allura Xper series is intended recalled by Philips North America
Philips North America is recalling The Allura Xper series is intended for use on human patients to perform: "Vascular, distributed nationwide in the US. The recall was initiated on 13 Aug 2021 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-2474-2021
- FDA event ID
- 88546
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Aug 2021
- FDA classified
- 14 Sep 2021
- Reported
- 22 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Pacemakers & Defibrillators
Timeline
| 13 Aug 2021 | Recall initiated by company | |
| 14 Sep 2021 | Classified by FDA | +32 days |
| 22 Sep 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may generate a peculiar burning smell that may be noticed. In some instances, this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality will be reduced.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. "Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). "Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures."
Where it was distributed
US Nationwide distribution in the states of ID, MA, MI, TX, VA.
Questions about this recall
Why was it recalled?
Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may generate a peculiar burning smell that may be noticed. In some instances, this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality will be reduced.
Which lots are affected?
Serial numbers: 48, 66, 67, 160
Where was it sold?
US Nationwide distribution in the states of ID, MA, MI, TX, VA.
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 88546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | The Azurion series (within the limits of the used Operation recalled | Philips North America | Device Malfunction | Nationwide | |
| CLASS II | The Allura Xper series is intended recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
More recalls from Philips North America
All 531| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Brilliance recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips IQon Spectral CT recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Ingenuity CT recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Brilliance CT 64: Brilliance CT 64 Channel recalled | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Cardiac Workstation recalled by Philips North America | Philips North America | Labeling Errors | Nationwide |
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