FDA (Devices) recall action 98111
The FDA (Devices) publishes a recall like this one as 13 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 13 pages.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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.
Aju Pharm is recalling 400 units of the Genesis Dual Thread Screw-In Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.
Philips North America is recalling 6 units of the Upgrade to MR 7700 because exported MR Elastography stiffness maps may show stiffness value errors.
Philips North America is recalling 3 units of the Evolution Upgrade 1.5T MR system because exported MR Elastography stiffness maps may show stiffness value errors.
Philips North America is recalling 6 units of the Ingenia 3.0T CX MR system because exported MR Elastography stiffness maps may show stiffness value errors.
Philips North America is recalling 21 units of the Ingenia Ambition X because exported MR Elastography stiffness maps may show stiffness value errors.
Philips North America is recalling 1 unit of the SmartPath to dStream for 3.0T because exported MR Elastography stiffness maps may show stiffness value errors.
Aju Pharm is recalling 233 units of the Fixone Hybrid Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.
Philips North America is recalling 10 units of the Ingenia 1.5T MR system because exported MR Elastography stiffness maps may show stiffness value errors.
Philips North America is recalling 3 units of the SmartPath to dStream for XR and 3.0T because exported MR Elastography stiffness maps may show stiffness value errors.
Philips North America is recalling 5 units of the Ingenia Elition S because exported MR Elastography stiffness maps may show stiffness value errors.
Philips North America is recalling 31 units of the Ingenia Elition X MR system because exported MR Elastography stiffness maps may show stiffness value errors.
Philips North America is recalling 1 unit of the Evolution Upgrade 3.0T MR system because exported MR Elastography stiffness maps may show stiffness value errors.
Philips North America is recalling 1 unit of the Ingenia Ambition S because exported MR Elastography stiffness maps may show stiffness value errors.