FDA (Devices) recall action 66976
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.
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 83 Vista and Vista Plus C-Arm X-Ray systems because an engineering change made the emergency switch an option rather than a standard component.
Ziehm Imaging Inc is recalling 60 Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.
Ziehm Imaging Inc is recalling 54 Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.
Ziehm Imaging Inc is recalling 58 Solo C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.
Ziehm Imaging Inc is recalling one Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System because an engineering change made the emergency switch an optional component.
Ziehm Imaging Inc is recalling 103 Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component.
Ziehm Imaging Inc is recalling 27 Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.