The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications...
⚠ Critical Alert — Stop Using Immediately
This product has been flagged with severe risks (fire or burn). Stop using it now and contact the brand or FDA for a refund, repair, or replacement.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2474-2021.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2474-2021.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Philips North America Llc or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2474-2021.
Philips North America Llc
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Philips North America Llc Recall FAQ
Philips North America Llc is the subject of a medical implants safety report: The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications.... The notice was published on August 13, 2021 by the U.S. Food and Drug Administration (FDA). Approximately 4 units are potentially affected.