FDA (Devices) recall action 93361
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
Potential component failure in the Gradient Coil could product smoke and/or fire.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Philips Ingenia 1.5T CX MRI systems may experience gradient coil failure that could produce smoke and/or fire. The FDA has classified this as a Class II recall affecting 48 units distributed nationwide and internationally.
Philips is recalling SmartPath to dStream 1.5T MRI systems due to a potential gradient coil failure that could produce smoke or fire. The recall affects 119 units distributed nationwide and internationally.
Philips is recalling the Intera 1.5T Power/Pulsar MRI system due to potential failure in the gradient coil component that could produce smoke and/or fire.
Philips is recalling Achieva 1.5T MRI systems because the gradient coil component could fail and produce smoke or fire. The recall affects 2 units distributed worldwide.
Philips is recalling Achieva 1.5T MRI systems due to potential gradient coil failure that could produce smoke and/or fire. Approximately 520 units have been distributed nationwide and internationally.
Philips is recalling 68 Achieva 1.5T MRI machines due to potential gradient coil component failure that could produce smoke and fire. No injuries have been reported.
Philips is recalling 102 Intera 1.5T MRI systems worldwide due to a potential gradient coil failure that could produce smoke and fire. The affected devices are identified by product numbers 781195 and 781295.