FDA-Device2013-05-29Class II
MyRay RXDC dental unit x-ray unit
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
Sold states
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.
Affected count
173 shipped to US
Manufactured in
VIA BICOCCA 14/C, N/A, IMOLA, BO, N/A, Italy
Products
MyRay RXDC dental unit x-ray unit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1217-2013Don't want to check this manually?
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