DreamStation Auto Non-Continuous Ventilator Recalled for Programming Error
Philips Respironics is recalling the DreamStation Auto Non-Continuous Ventilator due to a programming error that may result in incorrect device configuration affecting 28 units.
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: The FDA has classified this as a Class I recall, which requires a minimum severity score of 4. Although no illnesses or injuries have been reported in the available documentation, the programming error in a respiratory device poses a risk that warrants this classification.
Plain-English summary
Philips Respironics, Inc. is recalling the DreamStation Auto Non-Continuous Ventilator due to a programming error that may result in incorrect device configuration. A total of 28 units have been identified as affected.
The recalled devices were distributed in the United States in the following states: Alabama, California, Colorado, Florida, Georgia, Indiana, Louisiana, Maryland, Nebraska, New Jersey, New York, Pennsylvania, Texas, and Washington DC. Affected units were also distributed in France.
The recalled units are identified by specific serial numbers provided in the FDA recall notice. Owners of potentially affected devices should verify their serial number and seek further information from Philips Respironics or the FDA.
The recalled product
- Product
- DreamStation Auto. Non-Continuous Ventilator.
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- programming-error
- incorrect-configuration
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 (20)
- Model No. UFRX500S14
- UDI: 606959069824
- Serial No. J19093383C0FD
- J195817171415
- J195967969739
- J1999161223D4
- J208714453211
- J21638786344A
- J216718740A24
- J22792026797C
- J23016752559D
- J23025544A4CA
- J235207601E36
- J236974697023
- J24378890CB57
- J24404277EDBB
- J251606314EAA
- J255220797791
- J25755126C4A9
- J262274772766
Distribution
Distributed nationwide across the United States.
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