Z-1217-2013 Class II Terminated
FDA device recall Z-1217-2013 was initiated by CEFLA DENTAL GROUP on August 10, 2012 and is designated Class II. 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 … The recall status is terminated (terminated March 4, 2015). Affected quantity: 173 shipped to US.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2013
- Initiation Date
- August 10, 2012
- Termination Date
- March 4, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 173 shipped to US
Product Description
MyRay RXDC dental unit x-ray unit
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
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.
Code Information
Model - MyRay RX DC