Agency classClass IIOur severity:High FDA (Devices)·Z-0714-2016·Announced 2016-02-10

Philips Allura Xper OR Table Recalled for Image Interpretation Error

Philips is recalling Allura Xper OR Tables because still images may be mistaken for live images, potentially affecting diagnostic 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 involves a risk-of-harm product (medical imaging) where injury has not yet been reported, fitting the 'High' severity criteria for potential diagnostic errors without confirmed harm.

Plain-English summary

Philips Electronics North America Corporation is recalling the Allura Xper FD20/20 OR Table, Model Number 722039. The recall involves 13,297 units distributed worldwide, including the United States and numerous international markets.

The recall is due to a software issue where still images may be interpreted as live images on Allura Xper, Allura Clarity, Allura CV, Allura Centron, and UNIQ systems. This error could lead to misinterpretation of imaging data during diagnostic and interventional procedures.

Healthcare facilities using these devices should contact Philips for instructions on how to resolve the issue. No specific injuries or illnesses have been reported in the source text.

The recalled product

Product: Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent…
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Imaging Equipment
Hazard: mis-labeling
diagnostic-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