Summary
The FDA issued a Class I for DreamStation Auto BiPAP. Non-Continuous Ventilator. by Philips Respironics, Inc.. Reason: Devices may possess a programming error resulting in an incorrect device configuration..
Details
Source
Device Recall
External ID
Z-2228-2025
Action Date
2025-08-20
Status
Ongoing
Category
device
Product Description
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Lot/Code Info: Model No. UDSX700S11F; UDI: 606959429772; Serial No. J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, J301490021E77.
Quantity Affected: 8 units
Reason for Recall
Devices may possess a programming error resulting in an incorrect device configuration.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-30
Company
Murrysville, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 169 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Philips Respironics, Inc. has 74 FDA actions in our database, including 74 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Respironics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Respironics, Inc. have FDA actions?
Philips Respironics, Inc. has 74 FDA actions in our database, including 74 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2228-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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