Drug recall
Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit…
FDA recall event 70473 · Class II · Pivotal Health Solutions
Key facts
| Event ID | 70473 |
|---|---|
| Recall numbers | Z-1250-2015 |
| Recalling firm | Pivotal Health Solutions |
| Product type | Devices |
| Products | Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Control units were equipped with an internal mounting kit that does not meet medical safety standards, and are conductive, increasing the risk of electric shock to the user and patient. These units… |
| Initiation date | Dec 17, 2014 |
| Report date | Mar 18, 2015 |
| Termination date | Mar 9, 2016 |
| City | Watertown |
| State | SD |
| Country | United States |
| FEI number | 3007278668 |
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: