Drug recall
MyRay RXDC dental unit x-ray unit
FDA recall event 65036 · Class II · CEFLA DENTAL GROUP
Key facts
| Event ID | 65036 |
|---|---|
| Recall numbers | Z-1217-2013 |
| Recalling firm | CEFLA DENTAL GROUP |
| Product type | Devices |
| Products | MyRay RXDC dental unit x-ray unit |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 10, 2012 |
| Report date | May 29, 2013 |
| Termination date | Mar 4, 2015 |
| City | IMOLA, BO |
| Country | Italy |
| FEI number | 3006610845 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: