Agency classClass IIOur severity:High FDA (Devices)·Z-0715-2016·Announced 2016-02-10

Philips Allura Medical Imaging Systems Recalled for Image Interpretation Error

Philips is recalling Allura CV20 systems because a software issue may cause still images to be mistaken for live images during medical procedures.

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 FDA classified this as a Class II recall. The hazard involves a risk of misinterpretation of medical images, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Philips Electronics North America Corporation is recalling 13,297 units of the Allura CV20 medical imaging system (Model Number 722031). The recall covers all serial numbers and includes distribution in the United States (including Puerto Rico) and numerous countries worldwide.

The recall was initiated because the use of Allura Xper, Allura Clarity, Allura CV, Allura Centron, and UNIQ systems regarding live and still images can lead to still images being interpreted as live images. This error could affect physicians and trained hospital staff performing diagnostic and interventional procedures.

The FDA has classified this as a Class II recall. No specific injuries or illnesses have been reported in the source text. Users of these systems should contact Philips for instructions on how to resolve the issue.

The recalled product

Product: Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250…
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Imaging Systems
Hazard: mis-labeling
software-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