Philips Respironics V60 Ventilator Part Number DU1053617 — Class II medical device recall Z-0916-2021
Ongoing recall by Respironics California, LLC, reported 2021-02-03, distributed nationwide. Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may beco
| Recall number | Z-0916-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Respironics California, LLC, Carlsbad, CA, United States |
| Recall initiated | 2020-11-02 |
| Classified | 2021-01-22 |
| Reported by FDA | 2021-02-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GH, GR, GT, HK, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE, KR, LB, LU, LV, MA, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, SA, SE, SG, SI, TH, TR, TW, UA, VE, VN, ZA |
| Serial numbers | 100002908, 100002911, 100002913, 100002914, 100002916, 100002959, 100003001, 100003003, 100003005, 100003007, 100003018, 100003046, 100003052, 100003081, 100003674, 100003675, 100003685, 100003689, 100003728, 100003736, 100003757, 100003909, 100003910, 100003913, 100003916 and 475 more |
| Model numbers | DU1053617, U1053617, V60 |
Product
Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Note: U1053617 added 1/29/2021 after noticing it had been inadvertently left off
Reason for recall
Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
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-0916-2021. 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.