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Terminated

MyRay RXDC dental unit x-ray unit

FDA Recall Z-1217-2013 · Posted 2013-05-23

Recalling FirmCEFLA DENTAL GROUP
Recall StatusTerminated
Product CodeEHD
Date Initiated2012-08-10
Date Terminated2015-03-04
Product Quantity173 shipped to US

Reason for Recall

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

Firm Action

The firm, CEFLA Dental Group will update the user's manual to include the information required by 21 CFR 1020.30(h). Future production will ensure that system labels required by 21 CFR 1010.2, and 1020.30(e) are properly applied including the 53 units manufactured awaiting shipment. The updated user's manual will be made available online for free download. Alternatively, system purchasers, subsequent transferees, dealers and distributors may elect to receive a hard copy of the updated user's manual at no charge. All corrections will be made at no cost to the purchaser, subsequent transferee, dealer, or distributor. The above actions will be completed within 4 weeks. For further questions please call 1-800 323-2690.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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