Philips recalls Allura Xper systems with Certeray X-ray Generators in 480V regions due to risk of overheating and reduced X-ray performance from early ADU5 failures.
There is an increase in the failure rate of certain Anode Drive Units (ADU5) used in these products. 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 also 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 is reduced.
Philips is recalling Allura Xper systems with Certeray X-ray Generators sold in regions using 480V mains voltage. These systems may experience overheating of internal components, leading to reduced X-ray performance and potential burning smells. Affected units could have a failure that stops imaging procedures.
The Anode Drive Units (ADU5) in these systems can overheat when powered by 480V mains electricity, which is common in some regions. This overheating may cause a burning smell and reduce X-ray performance to emergency fluoroscopy, preventing standard imaging procedures.
Healthcare facilities using Philips Allura Xper systems in regions with 480V electrical systems are most at risk. Patients undergoing vascular or cardiac procedures with these systems may be affected.
Check for model numbers 722026 through 722079 and 1120 on the product label. These systems were sold in regions with 480V electrical systems for medical imaging procedures.
If you notice a burning smell, stop using the system immediately.
Check the model number on the product label to confirm if it is affected.
Reach out to Philips for guidance on next steps if you have an affected model.
The recall is due to an increased failure rate of Anode Drive Units (ADU5) in systems powered by 480V mains electricity, which can cause overheating and reduced X-ray performance.
If the ADU fails, the X-ray system will reduce to emergency fluoroscopy mode, preventing standard imaging procedures and reducing image quality.
No, only specific models sold in regions with 480V electrical systems, including model numbers 722026 through 722079 and 1120.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0716-2018 — Philips Philips Hello, I own a Philips that is covered by recall Z-0716-2018 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.