Agency classClass IIOur severity:High FDA (Devices)·Z-0726-2016·Announced 2016-02-10

Philips INTEGRIS Allura 9 Biplane Recalled for Image Interpretation Risk

Philips is recalling INTEGRIS Allura 9 Biplane systems because still images may be misinterpreted as live images, posing a risk to patient safety.

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 the misinterpretation of medical images (still vs. live), which is a risk-of-harm product issue where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Philips Electronics North America Corporation is recalling the INTEGRIS Allura 9 (biplane) system, Model Number 722021. The recall involves 13,297 units distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous international countries.

The recall is due to a software issue affecting the Allura Xper, Allura Clarity, Allura CV, Allura Centron, and UNIQ systems. The defect can cause still images to be interpreted as live images. This misinterpretation of medical imaging data may lead to incorrect clinical decisions or patient harm.

Healthcare facilities and users of these systems should contact Philips for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: INTEGRIS Allura 9 (biplane); Model Number: 722021 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and…
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Imaging Equipment
Hazard: mis-labeling
image-interpretation-error
Affected units: 13,297

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 29 recalled by Philips Electronics North America Corporation 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 29 products in this recall →

Same manufacturer · Philips Electronics North America Corporation

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Same hazard · mis labeling