Drug recall
SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of…
FDA recall event 77176 · Class II · Circadiance LLC
Key facts
| Event ID | 77176 |
|---|---|
| Recall numbers | Z-2250-2017 |
| Recalling firm | Circadiance LLC |
| Product type | Devices |
| Products | SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermittent operation of the nurse call feature. The firm has updated the device to increase the… |
| Initiation date | May 1, 2017 |
| Report date | Jun 14, 2017 |
| Termination date | Feb 5, 2018 |
| City | Export |
| State | PA |
| Country | United States |
| FEI number | 3006182632 |
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: