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Ziehm Imaging, Inc.

Last updated May 24, 2026

Information

Country: US
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DUNS Number: —

Catalogue (20)

Device	Model / Reference	Registries	Class	Status
Ziehm Vision RFD	Vision RFD	FDA UDI	Class II	Active
Ziehm Vision RFD 3D	Vision RFD 3D	FDA UDI	Class II	Active
Ziehm Solo	Solo	FDA UDI	Class II	Unknown
Ziehm Vision2 Vario	30237	FDA UDI	Class II	Unknown
Ziehm Vision FD	Vision FD	FDA UDI	Class II	Active
Ziehm Vision R	Vision R	FDA UDI	Class II	Unknown
Ziehm Solo FD	Solo FD	FDA UDI	Class II	Active
Ziehm Vision2	30355	FDA UDI	Class II	Unknown
Ziehm Vision2 FD Vario 3D	30238	FDA UDI	Class II	Unknown
Ziehm 8000	8000	FDA UDI	Class II	Unknown
Ziehm Vision2 FD Vario	30239	FDA UDI	Class II	Unknown
Ziehm Vision2 FD	30208	FDA UDI	Class II	Active
Ziehm Vision2 Vario 3D	30236	FDA UDI	Class II	Unknown
Ziehm Quantum	K051064	FDA 510(k)	Class II	Active
Ziehm Vision Fd Digital Mobile Imaging System	K061534	FDA 510(k)	Class II	Active
Ziehm Vision 2	K073346	FDA 510(k)	Class II	Active
Ziehm Vario 3d Digital Mobile Imaging System	K061310	FDA 510(k)	Class II	Active
Ziehm Vision Rfd	K083545	FDA 510(k)	Class II	Active
Ziehm Solo	K092438	FDA 510(k)	Class II	Active
Ziehm Vision R Digital Mobile Imaging System	K061203	FDA 510(k)	Class II	Active

Related Companies

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FDA Recalls (15)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 23, 2017	Z-1893-2017	—	terminated	During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component
Apr 15, 2016	Z-2643-2016	—	terminated	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.
Apr 15, 2016	Z-2640-2016	—	terminated	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.
Apr 15, 2016	Z-2642-2016	—	terminated	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.
Apr 15, 2016	Z-2641-2016	—	terminated	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.
Apr 15, 2016	Z-2639-2016	—	terminated	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.
Apr 15, 2016	Z-2644-2016	—	terminated	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.
Nov 21, 2013	Z-0567-2014	—	terminated	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.
Nov 21, 2013	Z-0564-2014	—	terminated	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.
Nov 21, 2013	Z-0562-2014	—	terminated	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.
Nov 21, 2013	Z-0565-2014	—	terminated	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.
Nov 21, 2013	Z-0566-2014	—	terminated	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.
Nov 21, 2013	Z-0568-2014	—	terminated	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.
Nov 21, 2013	Z-0563-2014	—	terminated	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.
Apr 29, 2011	Z-1430-2012	—	terminated	On 04/29/2011, Ziehm Imaging, Inc., Orlando, FL recalled the double foot switch, type KF 2 1S/1S-MED-AP, a component used with Ziehm Imaging GmbH Mobile C-arm due to the potential of unintentional continued activation of fluoroscopic X-ray as the foot switch may not become inactive when the pedal is released.