Agency classClass IIOur severity:High FDA (Devices)·Z-0716-2016·Announced 2016-02-10

Philips Allura Centron Medical Imaging System Recalled for Image Display Error

Philips is recalling Allura Centron systems because a software error may cause still images to be misinterpreted as 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 recall involves a risk-of-harm product (medical device) where the hazard is a potential misinterpretation of images, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Philips Electronics North America Corporation is recalling the Cardiovascular Allura Centron (Model Number: 722400) and other Allura and UNIQ systems. The recall involves 13,297 units distributed worldwide, including the United States and Puerto Rico. The affected systems are intended for use by physicians and trained hospital staff for various cardiovascular and non-vascular imaging and interventional procedures.

The recall is due to a software issue where the use of live images and still images can lead to still images being interpreted as live images. This error could potentially impact the interpretation of medical imaging data during procedures.

Healthcare facilities should contact Philips to determine if their systems are affected and to receive instructions for remediation. Patients who have undergone procedures using these systems should consult their healthcare providers if they have concerns about the accuracy of their imaging results.

The recalled product

Product: Cardiovascular Allura Centron; Model Number: 722400 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…
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Imaging System
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

See all →

High
Philips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors
FDA (Devices) · 2018-12-26
Moderate
Philips IntelliVue MX40 Patient Monitor Speaker Volume Recall
FDA (Devices) · 2018-12-19
High
Philips Medical Monitor Ceiling Suspension Recall for Detachment Risk
FDA (Devices) · 2018-10-03
High
Philips Allura Xper FD2O Ceiling Monitor Suspension Recall
FDA (Devices) · 2018-10-03
High
Philips AlIura Xper F010 F Monitor Ceiling Suspension Recall
FDA (Devices) · 2018-10-03

Same hazard · mis labeling