Z-2227-2025 Class I Ongoing
FDA device recall Z-2227-2025 was initiated by Philips Respironics, Inc. on June 30, 2025 and is designated Class I. Reason for recall: Devices may possess a programming error resulting in an incorrect device configuration. The recall status is ongoing. Affected quantity: 57 units.
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
- 57 units
Product Description
DreamStation Auto CPAP. 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. 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.