Philips Allura Xper Medical Imaging Systems Recalled for Shutter Reset Issue
Philips Healthcare is recalling 459 Allura Xper systems because shutter positions reset when procedure types change, potentially affecting imaging accuracy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional defect in a medical device used for diagnostic and interventional procedures, which poses a risk of harm through inaccurate imaging, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Healthcare is recalling 459 Allura Xper medical imaging systems distributed nationwide in the United States. The affected systems run software versions 8.1.25, 8.1.25.1, 8.1.25.5, 8.2.25, 8.2.25.5, and 8.2.27. These devices are used for vascular, cardiovascular, and neurovascular imaging, as well as cardiac diagnostics and interventional procedures.
The recall is due to a software defect where the shutter position resets to the open position the first time an operator selects a new procedure type during a single examination. If the shutters had been adjusted previously during that examination, those settings are not retained after the procedure type is changed. This issue may impact the accuracy of imaging during complex or multi-step procedures.
Healthcare facilities using these systems should contact Philips Healthcare for instructions on how to resolve the issue. No specific instructions for end-users are provided in the source text, as the product is intended for professional medical use.
The recalled product
- Product
- Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as
- Manufacturer
- Philips Healthcare
- Category
- Medical Device — Imaging Systems
- Affected units
- 459
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Philips Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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