FDA Device recall Z-1217-2013
MyRay RXDC dental unit x-ray unit
- FDA Device
- Class II
- terminated
- Published 2013-05-29
On 2013-05-29 the FDA classified a Class II recall of MyRay RXDC dental unit x-ray unit by Cefla Dental Group, citing 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. Th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1217-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-10 |
| Published | 2013-05-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cefla Dental Group |
| Distribution | AL, CA, CO, CT, FL, GA, IL, LA, MA, MD, MI, NC, NJ, NM, NY, PA, SC, TX, VA, WA, WI, WY |
Product
MyRay RXDC dental unit x-ray unit
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
Identifiers
| code_info | Model - MyRay RX DC |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1217-2013%22
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