Philips Respironics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2227-2025)
See the recall detail below. You can also see other recalls from the same firm in 2025.
DreamStation Auto CPAP. Non-Continuous Ventilator.
Class I
Devices may possess a programming error resulting in an incorrect device configuration.
Model No. UDSX500S11F; UDI: 606959429765; Serial No. J204432084D03, J206957368810, J207023218478, J21450857096A, J219786492F58, J222909239F3E, J22718022B9D6, J22924665CF8A, J230303131D07, J23148826984B, J23307132CC16, J2379520271A4, J23933071851F, J23963189F617, J242941498857, J243763392C02, J24551698A015, J247575014664, J24858283A8C3, J24994323EB40, J2529261301FF, J2543728920D9, J254401628C83, J25467463E51E, J25493556DA17, J254990254097, J255312624BAB, J256278994969, J25782569130A, J257828377BB3, J260977942F33, J2617246993BE, J26312750F8BD, J263183345586, J26751119CCB4, J27018735B4C6, J270987383503, J271152226FB8, J27220570C1F1, J27464550B547, J275917117696, J277824942640, J282846981F7D, J28582229DE76, J2901054169AB, J2902459395E1, J2921836070C5, J29746839268B, J2982204155F4, J299187060F67, J29925204838B, J299567590A7A, J2997189741CA, J30005981C03D, J301116505688, J3067824786A4, J30982199BB1D.
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.
Voluntary: Firm initiated