Skip to content
Recall Observatory FDA recall evidence

Device product

DreamStation Auto CPAP. Non-Continuous Ventilator.

Z-2227-2025

June 30, 2025

Class I

Product summary

Firm
Philips Respironics, Inc.
Event
Event 97191
Status
Ongoing
Classification
Class I
Quantity
57 units
Official record key
device-enforcement:Z-2227-2025

Official wording

Reason: Devices may possess a programming error resulting in an incorrect device configuration.

Code information: 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.

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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    programming error