FDA Medical Device Recalls (openFDA)
CEFLA DENTAL GROUP: MyRay RXDC dental unit x-ray unit
- Recall number
- Z-1217-2013
- Recalling firm
- CEFLA DENTAL GROUP
- Product
- MyRay RXDC dental unit x-ray unit
- Status
- Terminated
- Initiated
- 2012-08-10
- Posted
- 2013-05-23
- Terminated
- 2015-03-04
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Model - MyRay RX DC
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EHD
- Firm FEI
- 3006610845
- Firm city
- IMOLA BO
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28