FDA (Devices) recall action 74013
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
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.
Ziehm Imaging Inc is recalling 31 mobile C-arm devices because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.
Ziehm Imaging Inc is recalling 12 Ziehm Solo Mobile C-arms because the radiation-warning timer and 3D-specific interval warning may fail to alert users until the unit is rebooted.
Ziehm Imaging is recalling 14 mobile C-arm devices because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.
Ziehm Imaging Inc is recalling two Ziehm Vision RFD mobile C-arms because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.
Ziehm Imaging Inc is recalling two Ziehm Vision2 mobile C-arm devices because the radiation-warning timer and 3D-specific interval warning malfunction, preventing alerts until the unit is rebooted.
Ziehm Imaging Inc is recalling one Ziehm Vision R Mobile C-arm device because its radiation-warning timer and 3D-specific interval warning malfunction, preventing alerts until the unit is rebooted.