Embla Embletta Gold Recalled for Calibration Error Affecting Sleep Therapy
Embla System LLC is recalling 519 Embletta Gold polysomnography recorders due to a calibration error that may lead to over-titration of sleep therapy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a calibration error leading to potential over-titration of therapy, which is a risk of harm but does not involve reported injuries, deaths, or high-risk pathogens, fitting the Moderate criteria for a precautionary recall of a medical device.
Plain-English summary
Embla System LLC is recalling 519 units of the Embletta Gold polysomnography and ventilator effort recorder. The recall involves devices that were calibrated at the service center between June 15, 2012, and February 27, 2013. The Embletta Gold is a battery-operated device used to record physiologic signals for the diagnosis of sleep disorders in adult and pediatric patients, excluding neonates and infants.
The recall is due to a calibration error that could cause clinicians to over-titrate patients, potentially resulting in the prescription of a therapy pressure higher than necessary. The affected units were distributed nationwide in the United States and in Canada.
Healthcare facilities and consumers should check their device serial numbers against the list provided in the official recall notice. If a device is affected, it should be returned to Embla System LLC for evaluation and correction. The device is not equipped with an alarm and is not intended to be used as a life monitor.
The recalled product
- Product
- 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 of sleep disorders. It is intended to be used for adult and pediatric…
- Manufacturer
- Embla System Llc
- Affected units
- 519
Distribution
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