CEFLA DENTAL GROUP: Medical Device Recall in 2013 - (Recall #: Z-1217-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

MyRay RXDC dental unit x-ray unit

Product Classification:

Class II

Date Initiated: August 10, 2012

Date Posted: May 29, 2013

Recall Number: Z-1217-2013

Event ID: 65036

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

Status: Terminated

Product Quantity: 173 shipped to US

Code Information:

Model - MyRay RX DC

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.

Voluntary or Mandated:

Voluntary: Firm initiated