Ziehm Vision FD C-Arm X-Ray System Recalled for Emergency Switch Change
Ziehm Imaging Inc is recalling one Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System 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 a 'minor non-conformity' and the agency classification is Class II. There are no reported injuries, illnesses, or deaths, and the hazard is a component configuration change rather than a high-risk pathogen or structural failure.
Plain-English summary
Ziehm Imaging Inc is recalling one Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. The recall is due to an engineering change made in 2006 that resulted in a minor non-conformity of the devices.
Specifically, the emergency switch was changed from a standard component to just an option on the devices. The agency classifies this recall as Class II.
The device was distributed nationwide in the United States, including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Hawaii. The source text does not specify instructions for consumers or healthcare providers on how to resolve this issue.
The recalled product
- Product
- Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
- Manufacturer
- Ziehm Imaging Inc
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 90842
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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