DreamStation Auto BiPAP Ventilators Recalled Due to Programming Error
Philips is recalling 8 DreamStation Auto BiPAP ventilators due to a programming error that may result in incorrect device configuration. Affected units are distributed nationwide and in France.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. The recalled device is respiratory support equipment, and a programming error resulting in incorrect device configuration could affect proper operation.
Plain-English summary
Philips Respironics, Inc. is recalling 8 DreamStation Auto BiPAP Non-Continuous Ventilators due to a programming error affecting device configuration.
The recalled devices may possess a programming error that results in incorrect device configuration. This error could affect the proper setup and operation of the ventilators.
The affected units have been distributed nationwide in Alabama, California, Colorado, Florida, Georgia, Indiana, Louisiana, Maryland, Nebraska, New Jersey, New York, Pennsylvania, Texas, and Washington D.C., as well as in France. The affected model is UDSX700S11F with the following serial numbers: J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, and J301490021E77.
The recalled product
- Product
- DreamStation Auto BiPAP. Non-Continuous Ventilator.
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- software-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Model No. UDSX700S11F
- UDI: 606959429772
- Serial No. J18909076CC90
- J2091514323C5
- J2164570462CB
- J23391208BCBE
- J26552747A030
- J2909781691D2
- J294724447698
- J301490021E77.
Distribution
Distributed nationwide across the United States.
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