Philips recalls Allura Xper R8.x and UNIZ systems with FlexVision monitors due to potential screen freezing during long procedures, which may disrupt imaging. Affected units include specific model numbers and versions.
After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself.
Philips is recalling certain interventional fluoroscopy systems that may cause the large screen monitor to freeze for up to 15 seconds after more than 1.5 days of continuous use. This could disrupt medical procedures and lead to potential errors in patient imaging.
After continuous operation for over 1.5 days, the large screen monitor may freeze for about 15 seconds before restarting. This interruption could cause delays or errors in real-time imaging during critical medical procedures like angiography or stent placements.
Medical professionals using Philips Allura Xper R8.x and UNIZ systems with FlexVision large screen monitors are most at risk. Patients undergoing procedures with these systems may be affected if the freeze causes imaging errors.
Check for model numbers including Allura Xper R8.1.25.0 to R8.2.27, UNIZ Ri .0.10, or UNIZ Ri .0.10.5. The system must have a FlexVision large screen monitor to be affected.
Identify your system model from the list of affected units provided in the recall notice.
No, the recall does not require immediate discontinuation. The system may continue to be used with the risk of temporary screen freezes after prolonged operation.
The system will automatically restart after approximately 15 seconds, but this interruption could potentially disrupt imaging and require adjustments during the procedure.
Check if your system model is listed in the affected models (Allura Xper R8.x series or UNIZ Ri .0.10) and includes a FlexVision large screen monitor.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1589-2018 — Philips Philips Hello, I own a Philips that is covered by recall Z-1589-2018 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.
