Recall Z-1936-2025— Philips North America
Class II · Ongoing
Class II FDA medical device recall by Philips North America, initiated 2025-05-29. FDA's recall record names no specific 510(k) clearance for this event. Product: SmartPath to dStream for 1.5T¿; Product Number: 782146;. Reason: identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce 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 even death. This issue could also lead to property damage..
- Recalling firm
- Philips North America
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-05-29
- Firm location
- Cambridge, MA, United States
Product description
SmartPath to dStream for 1.5T¿; Product Number: 782146;
Reason for recall
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce 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 even death. This issue could also lead to property damage.
Data sourced from openFDA. This site is unofficial and independent of the FDA.