FDA (Devices) recall action 75851
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.
GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.
The agency’s own wording, quoted from the enforcement report.
GE Healthcare is recalling specific CRT monitors due to a risk that aged units may fall. The recall affects multiple imaging system models.
GE Healthcare is recalling Innova 2000 and other systems because aged CRT monitors may fall. The recall covers 1,598 units in the US and abroad.
GE Healthcare is recalling Prestilix and other systems because aged CRT monitors may fall. The recall covers 1,598 units in the US and overseas.
GE Healthcare is recalling specific X-ray systems because aged CRT monitors may fall. The recall covers 1,598 units distributed in the US and internationally.
GE Healthcare is recalling ADVANTX LCV+ systems because aged CRT monitors may fall. The recall covers 1,598 units distributed in the US and internationally.
GE Healthcare is recalling specific CRT monitors due to the potential for the units to fall. The recall affects multiple system models including ADVANTX and Prestige.
GE Healthcare is recalling Precision 500D and other systems because aged CRT monitors may fall.
GE Healthcare is recalling Prestige II and other systems because aged CRT monitors may fall. The recall covers 1,598 units in the US and abroad.
GE Healthcare is recalling RFX and other systems because aged CRT monitors may fall. This poses a risk of injury or property damage.
GE Healthcare is recalling ADVANTX LCA and other systems because aged CRT monitors may fall. The recall covers 1,598 units in the US and internationally.
GE Healthcare is recalling Prestige VH and other medical systems because aged CRT monitors may fall.
GE Healthcare is recalling Legacy and other imaging systems because aged CRT monitors may fall. The recall covers 1,598 units distributed in the US and internationally.
GE Healthcare is recalling Prestige SI and other systems because aged CRT monitors may fall. The recall covers 1,598 units in the US and overseas.