Health Products

Philips Achieva and Ingenia Systems

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Philips Achieva and Ingenia Systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Achieva 3.0T MRI System - Main UnitAll lots.ACHIEVA 3.0T
Ingenia 1.5TAll lots.781315
Ingenia 1.5TAll lots.1.5T
Ingenia 1.5TAll lots.782115
Ingenia Elition XAll lots.782107
Ingenia Elition XAll lots.781358
MR 7700All lots.782153
Ingenia 3.0T CXAll lots.781271
Ingenia 3.0TAll lots.3.0T
Ingenia Ambition SAll lots.782108
Ingenia Ambition SAll lots.782139
Achieva XR System - Main UnitAll lots.ACHIEVA XR
Ingenia Ambition XAll lots.782109
Ingenia Ambition XAll lots.781356
Ingenia Ambition XAll lots.782138

Issue

Philips has identified an issue where component failures in the gradient coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. If a component failure occurs, the user may observe the following: repeated scan abort error messages due to gradient amplifier fault detection unusual noise from the system in the examination or technical room burning smell smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or death. This issue could also lead to property damage. The scope includes MR systems with gradient coil types WA15, WA30S, WB30S, and AG30S. Recall start date: July 7, 2025

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