Philips Achieva and Ingenia Systems
Summary
Contact the manufacturer if you require additional information.
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 |
Ingenia Elition X |
All lots. |
782136 |
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
Philips Medical Systems Nederland B.V.
Veenpluis 6, Best, Netherlands, 5684 PC
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