Agency classClass IIOur severity:High FDA (Devices)·Z-2498-2018·Announced 2018-08-01

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Hazard: software-defect
imaging-inaccuracy
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.

See all 3 products in this recall →

Same manufacturer · Philips Healthcare

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Same hazard · software defect