DeVilbiss DV5x Series CPAP Units Recalled for Missing Serial Numbers
DeVilbiss Healthcare LLC is recalling 1,809 DV5x Series CPAP units because they were shipped without programmed serial numbers, displaying 'RUN-TEST' on the screen.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/programming defect (missing serial number) rather than a functional safety hazard.
Plain-English summary
DeVilbiss Healthcare LLC is recalling 1,809 units of the DeVilbiss Model DV5x Series CPAP. These devices are used in home and clinical environments to treat Obstructive Sleep Apnea (OSA) by applying positive air pressure.
The recall was initiated because a limited number of these units were manufactured and shipped without the serial number programmed into the device. As a result, the unit's serial number appears as "RUN-TEST" on the LCD display. The affected units were distributed nationwide in the USA and in Colombia, Honduras, Iran, Thailand, and Uruguay.
Consumers should check the LCD display of their CPAP unit. If the serial number displays as "RUN-TEST," the unit is affected by this recall. The source text does not specify a corrective action or contact information for consumers.
The recalled product
- Product
- DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.
- Manufacturer
- DeVilbiss Healthcare LLC
- Hazard
- Affected units
- 1,809
Distribution
Distributed nationwide across the United States.
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