CLASS II Device recall · Reported 29 May 2013 · FDA Enforcement Report

MyRay RXDC dental unit x-ray unit recalled by Cefla Dental Group

Cefla Dental Group is recalling MyRay RXDC dental unit x-ray unit, distributed in 22 states. The recall was initiated on 10 Aug 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel - MyRay RX DC

Quantity recalled173 shipped to US

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1217-2013
FDA event ID: 65036
Recalling firm: Cefla Dental Group, IMOLA, BO, N/A
Classification: Class II
Status: Terminated
Recall initiated: 10 Aug 2012
FDA classified: 23 May 2013
Reported: 29 May 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Imaging Equipment

Timeline

10 Aug 2012	Recall initiated by company
23 May 2013	Classified by FDA	+286 days
29 May 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

MyRay RXDC dental unit x-ray unit

Where it was distributed

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.

Alabama California Colorado Connecticut Florida Georgia Illinois Louisiana Massachusetts Maryland Michigan North Carolina New Jersey New Mexico New York Pennsylvania South Carolina Texas Virginia Washington

Questions about this recall

Is MyRay RXDC dental unit x-ray unit recalled?

Yes. Cefla Dental Group recalled MyRay RXDC dental unit x-ray unit on 10 Aug 2012. The recall is Class II and its status is Terminated. Recall number Z-1217-2013.

Why was it recalled?

Which lots are affected?

Model - MyRay RX DC

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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