FDA (Devices) recall action 91195
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Gradient Coil may act as a heat source with a potential to produce 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 is recalling the Upgrade to MR 7700 System (Model 782130) because the gradient coil may act as a heat source and produce smoke or fire. Affected units should not be operated until Philips provides further guidance.
Philips is recalling 566 Ingenia Elition X MRI systems nationwide. The gradient coil may act as a heat source with the potential to produce smoke and/or fire.
Philips SmartPath to Ingenia Elition X MR System models may produce smoke or fire due to gradient coil heat. Recall affects 566 units nationwide.
Philips is recalling 566 MR 7700 MRI systems nationwide. The gradient coil in these systems may overheat and produce fire or smoke.
Philips is recalling certain Ingenia Elition S MR Systems due to a potential fire or smoke hazard from the gradient coil. The affected units are distributed nationwide in the United States.