Ziehm Solo C-Arm X-Ray System Recalled for Emergency Switch Option
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.
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 reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a functional component change.
Plain-English summary
Ziehm Imaging Inc is recalling 58 units of the Ziehm Solo 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 Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
- Manufacturer
- Ziehm Imaging Inc
- Hazard
- Affected units
- 58
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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