FDA (Devices) recall action 94233
The FDA (Devices) publishes a recall like this one as 41 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 41 pages.
Patient support table floor plate may be incorrectly installed.
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 Evolution 3.0T MRI systems may have an incorrectly installed patient support table floor plate, creating a potential safety risk. Affected facilities should verify proper installation.
Philips GYROSCAN T5-NT MRI systems may have an incorrectly installed patient support floor plate. Affected units should be inspected to ensure proper installation.
Philips is recalling 46 units of the Intera 1.5T Achieva Nova MRI system due to improper installation of the patient support table floor plate. The defect may compromise patient safety during use.
Philips is recalling 347 Intera 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed, potentially compromising patient support stability during use.
Philips has recalled Intera 1.5T Achieva Nova-Dual MRI systems due to incorrect installation of the patient support table floor plate. The recall affects 20 units distributed worldwide.
Philips North America is recalling GYROSCAN T10-NT MRI systems due to potential incorrect installation of the patient support table floor plate. Affected units should be verified for proper installation.
Philips is recalling 69 units of the Achieva 1.5T Initial MRI system due to potential issues with the patient support table floor plate installation, which may affect patient safety during imaging.
Philips is recalling 1,921 Achieva 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed. Healthcare facilities should verify proper installation.
Philips is recalling 115 Achieva 1.5T MRI systems due to potential incorrect installation of the patient support table floor plate.
Philips is recalling certain Intera 1.5T MRI systems because the patient support table floor plate may be incorrectly installed, which could affect patient safety.
Philips is recalling 9 Intera 3.0T Quasar Dual MRI systems (Model 781150) distributed worldwide. The patient support table floor plate may be incorrectly installed on these units.
Philips is recalling 107 Intera 1.5T MRI systems worldwide due to potential incorrect installation of the patient support table floor plate, which may create safety risks during patient use.
Philips is recalling 344 Ingenia Ambition S MRI systems because the patient support table floor plate may be incorrectly installed.
Philips Intera 1.0T MRI systems may have an incorrectly installed patient support table floor plate. This defect could affect patient safety during magnetic resonance imaging procedures.
Philips is recalling 135 Ingenia 1.5T S MRI systems worldwide because the patient support table floor plate may be incorrectly installed, creating a potential safety risk to patients and staff.
Philips is recalling 14 Intera 0.5T MRI systems due to potential misinstallation of the patient support table floor plate, which could affect equipment stability and patient safety.
Philips Intera CV MRI systems may have an incorrectly installed patient support table floor plate. Eight units have been recalled due to this installation defect.
Philips has recalled 50 units of its GYROSCAN ACS-NT MRI systems. The patient support table floor plate may be incorrectly installed, potentially posing a safety risk.
Philips is recalling 24 units of the Intera Achieva 1.5T Pulsar MRI System because the patient support table floor plate may be incorrectly installed. Worldwide distribution affected.
Philips North America is recalling 131 Ingenia Elition S magnetic resonance imaging systems due to incorrect installation of the patient support table floor plates.
Philips has recalled 143 Ingenia 1.5T CX MRI systems due to potential incorrect installation of the patient support table floor plate affecting worldwide distribution.
Philips recalls 25 Intera 1.5T R11 MRI systems due to potential incorrect installation of the patient support table floor plate, which may affect patient safety during device operation.
Philips is recalling 33 Enterprise 1.5T MRI systems due to patient support table floor plates that may be incorrectly installed.
Philips is recalling the Achieva 3.0TX PET-MRI system because the patient support table floor plate may be incorrectly installed.
Philips is recalling one Achieva 3.0T for PET MRI system with a patient support table floor plate that may be incorrectly installed.