MyRay RXDC dental unit x-ray unit — Class II medical device recall Z-1217-2013
Terminated recall by CEFLA DENTAL GROUP, reported 2013-05-29, distributed in AL, CA, CO, CT, FL, GA, IL, LA…. The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifica
| Recall number | Z-1217-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CEFLA DENTAL GROUP, IMOLA, BO, N/A, Italy |
| Recall initiated | 2012-08-10 |
| Classified | 2013-05-23 |
| Reported by FDA | 2013-05-29 |
| Terminated | 2015-03-04 |
| Distributed | AL, CA, CO, CT, FL, GA, IL, LA, MA, MD, MI, NC, NJ, NM, NY, PA, SC, TX, VA, WA, WI, WY |
| Countries outside the US | CA |
| Quantity | 173 shipped |
| Reason classes | labeling, packaging |
Product
MyRay RXDC dental unit x-ray unit
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1217-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.