Reported May 29, 2013 · Terminated
MyRay RXDC dental unit x-ray unit
Cefla Dental Group
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CEFLA DENTAL GROUP · VIA BICOCCA 14/C · IMOLA, BO, N/A · N/A
Is this the product you have?
- MyRay RXDC dental unit x-ray unit
- Lot codes and dates
- Model - MyRay RX DC
- Amount recalled
- 173 shipped to US
Where it was sold
Why it was recalled
The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifically, 1. The tube housing did not contain a Certification label. 2. The collimator did not contain an identification label. 3. The user's manual did not contain leakage technique factors, tube housing cooling curves and rating charts, and technique factors which lead to operation at ma
This product could cause temporary or reversible health problems — stop using it.
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