Drug recall
Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International)…
FDA recall event 67150 · Class II · Optimedica Corporation
Key facts
| Event ID | 67150 |
|---|---|
| Recall numbers | Z-0649-2014 |
| Recalling firm | Optimedica Corporation |
| Product type | Devices |
| Products | Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible… |
| Initiation date | Dec 20, 2013 |
| Report date | Jan 15, 2014 |
| Termination date | Jun 26, 2014 |
| City | Sunnyvale |
| State | CA |
| Country | United States |
| FEI number | 3005675890 |
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: