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CEFLA DENTAL GROUP recalls MyRay RXDC dental unit x-ray unit
Recalled May 29, 2013 · FDA recall Z-1217-2013 · CEFLA DENTAL GROUP
Hazard
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 · FDA Class II
Units
173 shipped to US
Sold at
FOREIGN: CANADA; DOMESTIC: GA, TX, IL, CA, FL, NY, MA, AL, NJ, SC, WA, LA, MD, WY, CT, NM, WI, CO, NC, VA, PA and MI.
Description
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
Product
MyRay RXDC dental unit x-ray unit
Manufacturer(s)
CEFLA DENTAL GROUP
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →