Ziehm Imaging solo FD Mobile Fluoroscopic C-arm Recalled for Missing Label Date
Ziehm Imaging Inc is recalling two solo FD Mobile Fluoroscopic C-arm systems because the labels for the Collimator and X-ray Control panel are missing the manufacturer date.
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 recall is classified as FDA Class II and involves a labeling error (missing manufacturer date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ziehm Imaging Inc is recalling two units of the solo FD Mobile Fluoroscopic C-arm in the United States. The recall was initiated following an FDA inspection of Ziehm Imaging GmbH, which identified that the labels for the Collimator and X-ray Control panel were missing the manufacturer date. This date is required as part of the identification for certified components.
The affected devices are identified by serial numbers 52199 and 52108. These systems were distributed to the states of Florida and California. The source text indicates that no devices listed in this recall were distributed to foreign, military, or government consignees from the U.S.A.
This recall is classified as Class II by the FDA. Consumers and healthcare facilities should contact Ziehm Imaging Inc for further instructions regarding the correction of the missing label information.
The recalled product
- Product
- Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
- Manufacturer
- Ziehm Imaging Inc
- Hazard
- Affected units
- 2
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 (2)
- S/N 52199
- 52108
Distribution
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