Ziehm Vista C-Arm X-Ray Systems Recalled for Emergency Switch Change
Ziehm Imaging Inc is recalling 83 Vista and Vista Plus C-Arm X-Ray systems because an engineering change made the emergency switch an option rather than a standard component.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 a 'minor non-conformity' regarding an emergency switch, which fits the rubric for moderate severity involving low-risk issues or voluntary precautionary recalls without reported injuries.
Plain-English summary
Ziehm Imaging Inc is recalling 83 units of the Ziehm Vista and Vista Plus C-Arm Interventional Fluoroscopic X-Ray Systems. These are mobile fluoroscopic imaging devices distributed nationwide in the United States, including all 50 states and the District of Columbia.
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. This means some units may not have the emergency switch installed as a standard part of the system.
Healthcare facilities and users of these devices should contact Ziehm Imaging Inc to determine if their specific unit is affected and to arrange for the necessary corrective action to ensure the emergency switch is properly installed and functional.
The recalled product
- Product
- Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
- Manufacturer
- Ziehm Imaging Inc
- Hazard
- Affected units
- 83
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.
See all 7 products in this recall →Related recalls
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- HighZiehm Vision RFD Mobile C-arm Recalled for Radiation Warning Timer Malfunction
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