Health product recall

Philips Achieva and Ingenia Systems

Last updated

Summary

Product
Philips Achieva and Ingenia Systems
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Achieva 3.0T MRI System - Main Unit All lots. ACHIEVA 3.0T
Ingenia 1.5T All lots. 781315
Ingenia 1.5T All lots. 1.5T
Ingenia 1.5T All lots. 782115
Ingenia Elition X All lots. 782107
Ingenia Elition X All lots. 781358
MR 7700 All lots. 782153
Ingenia 3.0T CX All lots. 781271
Ingenia 3.0T All lots. 3.0T
Ingenia Ambition S All lots. 782108
Ingenia Ambition S All lots. 782139
Achieva XR System - Main Unit All lots. ACHIEVA XR
Ingenia Ambition X All lots. 782109
Ingenia Ambition X All lots. 781356
Ingenia Ambition X All 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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Philips Medical Systems Nederland B.V.

Veenpluis 6, Best, Netherlands, 5684 PC

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77750

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