Ziehm Vision R C-Arm X-Ray System Recalled for Emergency Switch Issue
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.
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 the agency classification is Class II, which aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary recalls without reported injuries.
Plain-English summary
Ziehm Imaging Inc is recalling 103 units of the Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. The recall was initiated due to a minor non-conformity resulting from an engineering change made in 2006.
The specific issue is that the emergency switch was changed from a standard component to an optional feature on the devices. This means some units may not have the emergency switch installed as a standard safety feature.
The affected devices were distributed nationwide in the United States, including all 50 states. The recall is classified as Class II by the FDA. Consumers and healthcare facilities should contact Ziehm Imaging Inc for further instructions on how to address this issue with their specific equipment.
The recalled product
- Product
- Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
- Manufacturer
- Ziehm Imaging Inc
- Hazard
- Affected units
- 103
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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