DeGotzen XGenus Dental X-ray Units Recalled for Labeling Defects
DeGotzen is recalling 159 XGenus dental X-ray units because method samples failed labeling and certification requirements.
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, but the source text identifies the issue as a failure to meet labeling and certification requirements without reporting injuries or illnesses, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
DeGotzen is recalling 159 units of the XGenus Dental X-ray unit. The recall was initiated after it was discovered that the method sample did not meet requirements for labeling and certification.
The affected units were distributed nationwide in the United States. The recall number is Z-1020-2013.
Consumers and dental practices should contact DeGotzen for further instructions regarding the recall.
The recalled product
- Product
- DeGotzen XRay unit XGenus Dental X-ray unit.
- Manufacturer
- DeGotzen
- Hazard
- Affected units
- 159
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)
- 766471
Distribution
Distributed nationwide across the United States.
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