Philips North America has recalled 36 units of various MRI systems, including several Achieva and Intera 1.5T models. A component failure in the gradient coil of these systems can act as a heat source, potentially leading to smoke or a fire during medical procedures. Philips has initiated this voluntary recall through direct notification letters to affected facilities to prevent potential patient and operator injuries.
The malfunctioning component can overheat and produce smoke or fire, posing serious risks including smoke inhalation, burns, or suffocation (asphyxia), which could lead to injury or death.
Recall #: Z-1928-2025; Quantity: 6 units (5 US, 1 OUS)
Recall #: Z-1929-2025; Quantity: 1 unit
Recall #: Z-1930-2025; Quantity: 16 units (1 US, 15 OUS)
Recall #: Z-1931-2025; Quantity: 3 units (1 US, 2 OUS)
Recall #: Z-1932-2025; Quantity: 1 unit (OUS only)
Recall #: Z-1933-2025; Quantity: 2 units (US only)
Recall #: Z-1934-2025; Quantity: 2 units (OUS only)
Recall #: Z-1935-2025; Quantity: 4 units (1 US, 3 OUS)
Recall #: Z-1936-2025; Quantity: 1 unit
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.