Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MyRay RXDC dental unit x-ray unit Recalled by CEFLA DENTAL GROUP Due to The RX DC dental x-ray unit was found...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CEFLA DENTAL GROUP directly.
Affected Products
MyRay RXDC dental unit x-ray unit
Quantity: 173 shipped to US
Why Was This 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
Where Was This Sold?
This product was distributed to 22 states: AL, CA, CO, CT, FL, GA, IL, LA, MD, MA, MI, NJ, NM, NY, NC, PA, SC, TX, VA, WA, WI, WY
About CEFLA DENTAL GROUP
CEFLA DENTAL GROUP has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report