Cefla Dental X-Ray Units Recalled for Missing Safety Labels
Cefla Dental Group is recalling 173 MyRay RXDC dental x-ray units because they lack required certification and identification labels.
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 describes missing labels and documentation issues rather than a defect causing injury or hospitalization, fitting the Moderate criteria for labeling errors.
Plain-English summary
Cefla Dental Group is recalling 173 MyRay RXDC dental x-ray units. The units were found to be noncompliant with FDA regulations 21 CFR 1010.2, 1020.30(e), and 1020.30(h). Specifically, the tube housing did not contain a certification label, and the collimator did not contain an identification label.
The user's manual for these units was also found to be incomplete. It did not contain leakage technique factors, tube housing cooling curves, rating charts, or technique factors that lead to operation at maximum allowable levels. The recall is classified as Class II by the FDA.
The affected units were distributed to dental practices in 22 US states, including Georgia, Texas, Illinois, California, Florida, New York, Massachusetts, Alabama, New Jersey, South Carolina, Washington, Louisiana, Maryland, Wyoming, Connecticut, New Mexico, Wisconsin, Colorado, North Carolina, Virginia, Pennsylvania, and Michigan. They were also distributed to Canada. Consumers and dental practices should stop using these units and contact the manufacturer for instructions.
The recalled product
- Product
- MyRay RXDC dental unit x-ray unit
- Manufacturer
- CEFLA DENTAL GROUP
- Affected units
- 173
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)
- Model - MyRay RX DC
Distribution
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