Agency classClass IIOur severity:High FDA (Devices)·Z-0710-2016·Announced 2016-02-10

Philips Allura Xper OR Table Recall for Image Interpretation Risk

Philips is recalling Allura Xper FD20 OR Tables because live and still images may be misinterpreted, 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 is classified as FDA Class II and involves a risk of harm (misinterpretation of medical images) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Philips Electronics North America Corporation is recalling the Allura Xper FD20 OR Table, including model numbers 722035 and 722023. The recall involves 13,297 units distributed worldwide, including the United States, Puerto Rico, and numerous international locations.

The recall is issued because the use of Allura Xper, Allura Clarity, Allura CV, Allura Centron, and UNIQ systems regarding live images and still images can lead to still images being interpreted as live images. This issue may affect the interpretation of diagnostic and interventional procedures.

Healthcare facilities should contact Philips for further instructions on how to address this issue. The recall is classified as Class II by the FDA.

The recalled product

Product: Allura Xper FD20 OR Table; Model Numbers: 722035 722023 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