FDA (Devices) recall action 96889
The FDA (Devices) publishes a recall like this one as 18 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 18 pages.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
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 certain SmartPath to dStream 1.5T medical imaging devices due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips is recalling certain Ingenia Ambition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips is recalling the SmartPath to dStream 3.0T medical device due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. This could affect image interpretation accuracy.
Philips Evolution Upgrade 1.5T medical imaging systems may display alignment errors in cross-reference line functionality when reviewing images via MobiView application.
Philips is recalling the Upgrade to MR 7700 (Model 782130) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. The misalignment could affect diagnostic accuracy.
Philips is recalling certain Ingenia 3.0T MRI systems worldwide due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips is recalling SmartPath to dStream for XR and 3.0T medical imaging software due to potential alignment errors in cross reference line functionality when reviewing images with the MobiView application.
Philips is recalling certain Ingenia Ambition S MRI devices due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application.
Philips is recalling MR 7700 model medical devices due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips is recalling MR 5300 medical devices (Model Numbers 782110 and 782152) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips has recalled specific Ingenia Elition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips is recalling certain Ingenia Elition S MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips is recalling the Ingenia 1.5T S magnetic resonance imaging (MRI) system due to potential alignment errors in cross reference line functionality when reviewing images generated with the MobiView application.
Philips is recalling SmartPath to Ingenia Elition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. The alignment errors could affect image interpretation.
Philips is recalling the Ingenia 3.0T CX MRI system due to potential alignment errors in the cross reference line when using the MobiView application to review images. The alignment error could affect image accuracy during review.
Philips is recalling Ingenia 1.5T MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application.
Philips is recalling Evolution Upgrade 3.0T MRI systems (Models 782117 and 782143) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips is recalling Ingenia 1.5T CX MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application. This could affect image interpretation.