FDAFDA · Food and drugs·Recall number Z-1217-2013
MyRay RXDC dental unit x-ray unit
Published May 29, 2013 · Recall initiated: August 10, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CEFLA DENTAL GROUP
- Distributor
- 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.
- Lot
- Model - MyRay RX DC
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Italy
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