Philips Healthcare recalls Allura Xper imaging systems for vascular and cardiac procedures due to shutter reset risk when changing procedure types during a single exam. Affected models include Allura 8.1.25 and 8.2.25 series. No immediate action required but check for specific model numbers.
The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.
Philips Healthcare is recalling Allura Xper imaging systems used for vascular, cardiovascular, and neurovascular procedures. The issue causes shutter positions to reset when changing procedure types during a single exam, potentially affecting patient safety if shutters were previously adjusted.
When an operator changes procedure types during a single exam, the system resets shutter positions to the open state for the new procedure. If shutters were previously adjusted during the exam, those settings are lost, which could lead to inconsistent imaging or safety issues.
Users of Philips Allura Xper imaging systems for cardiac procedures, vascular interventions, and minimally invasive surgeries are affected. Medical professionals performing these procedures are most at risk.
Check if your system is listed in the affected models: Allura 8.1.25, Allura 8.1.25.1, Allura 8.1.25.5, Allura 8.2.25, Allura 8.2.25.5, or Allura 8.2.27. These models are used for cardiac imaging, vascular procedures, and minimally invasive surgeries.
Identify your system's model number to confirm if it is affected by the recall.
The recall occurs because changing procedure types during a single exam causes shutter positions to reset, potentially affecting previously adjusted settings.
No immediate action is required. The recall does not mandate stopping use but requires checking model numbers.
Affected models include Allura 8.1.25, Allura 8.1.25.1, Allura 8.1.25.5, Allura 8.2.25, Allura 8.2.25.5, and Allura 8.2.27.
We’ve drafted a message you can send Philips Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2498-2018 — Philips Healthcare Philips Healthcare Hello, I own a Philips Healthcare that is covered by recall Z-2498-2018 from Philips Healthcare. 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.
