Ziehm Vision RFD C-Arm X-Ray System Recalled for Emergency Switch Change
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.
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 text explicitly describes the issue as a 'minor non-conformity' and the agency classification is Class II. There are no reports of injury, illness, or death, and the hazard is a configuration change rather than a high-risk pathogen or structural failure.
Plain-English summary
Ziehm Imaging Inc is recalling 27 units of the Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. The recall is due to an engineering change implemented in 2006 that resulted in a minor non-conformity. Specifically, the emergency switch was changed from a standard component to an optional feature 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.
Healthcare facilities should contact Ziehm Imaging Inc for instructions on how to address the non-conformity regarding the emergency switch configuration.
The recalled product
- Product
- Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
- Manufacturer
- Ziehm Imaging Inc
- Affected units
- 27
Distribution
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.
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