Data Foundry

Medical device recalls 2024

BiPAP V30 Auto Ventilator — Class I medical device recall Z-1812-2024

Ongoing recall by Philips Respironics, Inc., reported 2024-05-29, distributed nationwide. Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This m

Recall numberZ-1812-2024
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips Respironics, Inc., Murrysville, PA, United States
Recall initiated2024-03-26
Classified2024-05-23
Reported by FDA2024-05-29
DistributedNationwide (US)
Countries outside the USAT, BE, CY, CZ, DE, DK, ES, FR, HU, IT, NL, PL, PT, RO, RS, SK, TR
Quantity5,958 us
UPC / GTIN / UDI-DI00206864878339, 00212492192136, 00213532372839, 00214372232260, 00214482192577, 00214494554219, 00214811592320, 00215416047963, 00216765973514, 00216768340580, 00216768455901, 00219184839867, 00219428310084, 00219428463933, 00220345047465, 00222265958890, 00222266068277, 00222267280265, 00222267548501, 00225594618954, 00226593530056, 00227721760345, 00229768729231, 00231653891688, 00231653909291 and 75 more
Serial numbersN205345571B7A, N20534558E38D, N20534559F204, N2053456045AD, N205345615424, N2053456266BF, N205345637736, N205345640389, N205345651200, N20534566209B, N205345673112, N20534568C9E5, N20534569D86C, N205345705C75, N205345714DFC, N205345727F67, N205345736EEE, N205345741A51, N205345750BD8, N2068642229E4, N206864244CD2, N206864255D5B, N206864266FC0, N206864277E49, N2068642886BE and 475 more
Model numbers1111178

Product

BiPAP V30 Auto Ventilator, Part Number 1111178

Reason for recall

Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1812-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.