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U.S. Department of Health and Human Services

Class 2 Device Recall MY Ray RXDC xray unit

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  Class 2 Device Recall MY Ray RXDC xray unit see related information
Date Initiated by Firm August 10, 2012
Date Posted May 23, 2013
Recall Status1 Terminated 3 on March 04, 2015
Recall Number Z-1217-2013
Recall Event ID 65036
Product Classification Unit, x-ray, extraoral with timer - Product Code EHD
Product MyRay RXDC dental unit

x-ray unit
Code Information Model - MyRay RX DC
Recalling Firm/
Manufacturer		 CEFLA DENTAL GROUP
VIA BICOCCA 14/C
IMOLA, BO Italy
For Additional Information Contact Mr. Claude Berthoihn
800-323-2690
Manufacturer 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
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
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.
Quantity in Commerce 173 shipped to US
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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