OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124… — Class I medical device recall Z-1817-2024
Ongoing recall by Philips Respironics, Inc., reported 2024-05-29, distributed nationwide. Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may l
| Recall number | Z-1817-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2024-04-01 |
| Classified | 2024-05-23 |
| Reported by FDA | 2024-05-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| UPC / GTIN / UDI-DI | 00097782803066, 00097789159975, 00097789781640, 00097789911191, 00097893396594, 00097962653221, 00097963337373, 00097965816210, 00097967507659, 00098137265799, 00098138317039, 00098139858869, 00100103943751, 00100862638004, 00101193754180, 00102461613314, 00102987124868, 00103081783074, 00104081178082, 00106382615242, 00106812842170, 00109042192473, 00110227533240, 00110228200714, 00110456565388 and 155 more |
| Serial numbers | 1111122, 1111123, 1111124, 1111126, 1111127, 1111138, 1111141, 1111142, 645BB, 7965820, 84038575F, KR1111127, L0976588485F3, L09765885947A, L09765886A6E1, L097658884F9F, L097658895E16, L09765891CB86, L09765892F91D, L097658958DA2, L09765896BF39, L09765897AEB0, L097659014642, L097659036550, L097659050066 and 475 more |
Product
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
Reason for recall
Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.
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-1817-2024. 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.