Z-1217-2013Class II

MyRay RXDC dental unit x-ray unit

Name: Z-1217-2013 MyRay RXDC dental unit x-ray unit
Creator: Cefla Dental Group
Published: 2012-08-10
License: https://open.fda.gov/license/

Cefla S.C. / initiated 2012-08-10 / Terminated / root cause: labeling and UDI

FDA source

CEFLA DENTAL GROUP began a recall of MyRay RXDC dental unit x-ray unit on 2012-08-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1217-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-10
Posted: 2013-05-23
Terminated: 2015-03-04
Recalling firm: Cefla S.C.
Product: MyRay RXDC dental unit x-ray unit
Product code: EHD Unit, X-Ray, Extraoral With Timer
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
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: The firm, CEFLA Dental Group will update the user's manual to include the information required by 21 CFR 1020.30(h). Future production will ensure that system labels required by 21 CFR 1010.2, and 1020.30(e) are properly applied including the 53 units manufactured awaiting shipment. The updated user's manual will be made available online for free download. Alternatively, system purchasers, subsequent transferees, dealers and distributors may elect to receive a hard copy of the updated user's manual at no charge. All corrections will be made at no cost to the purchaser, subsequent transferee, dealer, or distributor. The above actions will be completed within 4 weeks. For further questions please call 1-800 323-2690.
Quantity in commerce: 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.
Product codes and lots: Model - MyRay RX DC

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1217-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1217-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-23

Product code EHD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)