BiPAP A40 Ventilators: BiPAP A40 — Class I medical device recall Z-1813-2024
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 number | Z-1813-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2024-03-26 |
| Classified | 2024-05-23 |
| Reported by FDA | 2024-05-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CY, CZ, DE, DK, ES, FR, HU, IT, NL, PL, PT, RO, RS, SK, TR |
| UPC / GTIN / UDI-DI | 00026970279475, 00028295888028, 00028301488808, 00028301595186, 00028301624022, 00029576007350, 00029578087558, 00029606560107, 00029666550018, 00029915166052, 00029917394293, 00029988722285, 00030140764593, 00030592531903, 00031372537139, 00031383410780, 00031453658463, 00031453708625, 00031454171336, 00031465825969, 00031467282555, 00031477334855, 00031477933829, 00031480594932, 00031546000032 and 475 more |
| Serial numbers | 0355ADF9, 036421439786C, 036665294DF8A, 048B3, 128AD46, 131, 23395870, 4167674A23, 6203593FBEE, 701DCB7, 78141034D2, 824F26, 8901078712, 8DA, A40, A40PRO, B026346777E8C1, B0263467898277, B026346794404A, B0263467966358, B02634679772D1, B0263467999BAF, B026346804DD95, B026346806FE87, B026346925A570 and 475 more |
| Model numbers | 1111169, ARX3100S19, AUX3000S19, AUX3100S19, BLX3100S19, BRX3100S18, CAX3100S12, CAX3100T12, DEX2900S13, DEX3000S13, DEX3100S13, EEX3000S19, EEX3100S19, ESX3000S19, ESX3100S19, FRX3000S14, FRX3100S14, GBX3000S19, GBX3100H19, GBX3100S19, IAX3100S19, INX3000H19, INX3100H19, INX3100S19, ITX3000S21 and 2 more |
Product
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19 AUX3100S19 BLX3100S19 BRX3100S18 CAX3100S12 CAX3100T12 DEX3100S13 EEX3100S19 ESX3100S19 FRX3100S14 GBX3100H19 GBX3100S19 IAX3100S19 INX3100H19 INX3100S19 ITX3100S21 SPX3100S19 ; BiPAP A40 EFL, Part Numbers (OUS Only): AUX3000S19 DEX2900S13 DEX3000S13 EEX3000S19 ESX3000S19 FRX3000S14 GBX3000S19 INX3000H19 ITX3000S21
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-1813-2024. 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.