Z-2228-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 20, 2025
- Initiation Date
- June 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Reason for Recall
Devices may possess a programming error resulting in an incorrect device configuration.
Distribution Pattern
Worldwide - US Nationwide in the states of AL, CA, CO, FL, GA, IN, LA, MD, NE, NJ, NY, PA, TX & DC. The country of France.
Code Information
Model No. UDSX700S11F; UDI: 606959429772; Serial No. J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, J301490021E77.