FDA (Devices) recall action 82038
The FDA (Devices) publishes a recall like this one as 64 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 64 pages.
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
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 11,226 Achieva 3.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling Ingenia 3.0T CX MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling 11,226 Achieva 7.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling Intera 1.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling Achieva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling Ingenia Elition S MRI systems because ceiling speakers may fall due to magnetic attraction.
Philips is recalling Intera 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling MARLIN 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling 11,226 Ingenia Ambition S MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling 11,226 Intera 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling 11,226 Panorama 1.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling 11,226 Intera 0.5T MRI systems because ceiling speakers may fall due to magnetic attraction.
Philips is recalling 11,226 Ingenia Ambition X MRI systems because ceiling speakers may fall due to magnetic attraction.
Philips is recalling Intera 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling SmartPath to dStream MRI systems because ceiling speakers may fall due to magnetic attraction.
Philips is recalling 11,226 Ingenia 3.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling 11,226 MR-OR 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling Multiva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling 11,226 Achieva XR MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling Intera Achieva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling Enterprise 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling Intera Achieva 1.5T Nova MRI systems because ceiling speakers may be pulled by the magnetic field and fall.
Philips is recalling 11,226 Achieva 3.0T MRI systems because ceiling speakers may fall due to magnetic attraction.
Philips is recalling Achieva 3.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Philips is recalling Multiva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.