The Recall Desk
ModerateFDA (Devices)·Z-0564-2014·Announced 2014-01-01

Ziehm Vision C-Arm X-Ray Systems Recalled for Emergency Switch Issue

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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The source describes the issue as a 'minor non-conformity' and a 'voluntary precautionary' engineering change without reported injuries or illnesses, aligning with the Moderate severity criteria for low-risk issues.

Plain-English summary

Ziehm Imaging Inc is recalling 60 units of the Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. These are mobile fluoroscopic imaging devices used for interventional procedures.

The recall was initiated because an engineering change in 2006 resulted in a minor non-conformity. Specifically, the emergency switch was changed from a standard component to just an option on the devices.

The affected devices were distributed nationwide in the United States, including Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Montana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming, and Hawaii. Consumers and healthcare facilities should contact Ziehm Imaging Inc for further instructions regarding the affected units.

The recalled product

Product
Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Manufacturer
Ziehm Imaging Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
60

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Ziehm Imaging Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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