MyRay RXDC dental unit x-ray unit recall
MyRay RXDC dental unit x-ray unit
Why was MyRay RXDC dental unit x-ray unit recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model - MyRay RX DC
- Product
- MyRay RXDC dental unit x-ray unit
- Recalling firm
- CEFLA DENTAL GROUP
- 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.
- Recall date
- May 29, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)