🔍 RecallPedia

MyRay RXDC dental unit x-ray unit

Class I - Dangerous
🏥 Medical Devices Recalled: August 10, 2012 CEFLA DENTAL GROUP Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model - MyRay RX DC
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
CEFLA DENTAL GROUP
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
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

MyRay RXDC dental unit x-ray unit

Product Codes/Lot Numbers:

Model - MyRay RX DC

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1217-2013