FDA recall Z-2227-2025

Philips Respironics, Inc. · Class I · device

Product

DreamStation Auto CPAP. Non-Continuous Ventilator.

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.

Key facts

Status
Ongoing
Initiation date
2025-06-30
Report date
2025-08-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Murrysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2227-2025