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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97191

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 30, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Philips Respironics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

DreamStation Auto CPAP. Non-Continuous Ventilator.

Z-2227-2025
Recall number
Z-2227-2025
Initiated
June 30, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
57 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
programming error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

device · product 2 of 3

DreamStation Auto BiPAP. Non-Continuous Ventilator.

Z-2228-2025
Recall number
Z-2228-2025
Initiated
June 30, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
8 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
programming error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model No. UDSX700S11F; UDI: 606959429772; Serial No. J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, J301490021E77.

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.

device · product 3 of 3

DreamStation Auto. Non-Continuous Ventilator.

Z-2229-2025
Recall number
Z-2229-2025
Initiated
June 30, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Philips Respironics, Inc.
Quantity
28 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
programming error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model No. UFRX500S14; UDI: 606959069824; Serial No. J19093383C0FD, J195817171415, J195967969739, J1999161223D4, J208714453211, J21638786344A, J216718740A24, J22792026797C, J23016752559D, J23025544A4CA, J235207601E36, J236974697023, J24378890CB57, J24404277EDBB, J251606314EAA, J255220797791, J25755126C4A9, J262274772766, J26263484C9C9, J26377226BCF1, J26525214B253, J2661985603DE, J26673715FBD4, J27099876ED61, J272180530173, J27467764497E, J305016887150, J30708300FB50.

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.