Recall Z-1217-2013 ยท EHD Unit, X-Ray, Extraoral With Timer
CEFLA DENTAL GROUP
MyRay RXDC dental unit x-ray unit
| Date | May 23, 2013 (initiated Aug 10, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.