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Health Canada Medical devices

Philips Achieva and Ingenia Systems

Issued July 18, 2025
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
Hazard description
Performance
Product
Product name
Philips Achieva and Ingenia Systems
Reference
ID
RA-77750