Drug recall
embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta…
FDA recall event 65175 · Class II · Embla System Llc
Key facts
| Event ID | 65175 |
|---|---|
| Recall numbers | Z-1532-2013 |
| Recalling firm | Embla System Llc |
| Product type | Devices |
| Products | embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Calibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, 2013. This calibration error could cause a clinician to over titrate the patient… |
| Initiation date | Apr 24, 2013 |
| Report date | Jun 19, 2013 |
| Termination date | Mar 7, 2017 |
| City | Tonawanda |
| State | NY |
| Country | United States |
| FEI number | 3009448422 |
At a glance
- 1–9 Products in this recall
- None 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: