Philips Healthcare recalls UNIQ products for vascular and cardiovascular imaging where shutter positions reset during procedure changes, potentially affecting patient safety. Learn if your device is affected and what to do.
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 certain UNIQ products used in vascular, cardiovascular, and neurovascular imaging procedures. The issue involves shutter positions resetting when changing procedure types during an exam, which could lead to incorrect settings affecting patient safety.
When an operator changes procedure types during a single exam, the shutter resets to the open position for the new procedure. If shutters were previously adjusted, those settings are lost after the first procedure change. This could lead to incorrect imaging settings affecting patient safety.
Users of Philips UNIQ products for vascular, cardiovascular, and neurovascular imaging procedures, including cardiac imaging and minimally invasive procedures. Patients undergoing these procedures are most at risk if the shutter reset causes incorrect settings.
Check for UNIQ 1.0.10 or UNIQ 1:0.10.5 software versions used in vascular, cardiovascular, and neurovascular imaging applications. These products are used for cardiac imaging, minimally invasive procedures, and interventional applications.
Verify your UNIQ product's software version is 1.0.10 or 1.0.10.5 by checking the device settings or documentation.
Yes, this recall affects UNIQ products used for cardiac imaging including diagnostics, interventional procedures, and minimally invasive applications.
The shutter reset could lead to incorrect imaging settings if procedure types are changed during an exam, potentially affecting patient safety.
No, the recall does not require immediate discontinuation. Users should check their software version and follow the provided steps.
We’ve drafted a message you can send Philips Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2499-2018 — Philips Healthcare Philips Healthcare Hello, I own a Philips Healthcare that is covered by recall Z-2499-2018 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.
