Respironics V60 Ventilator — Class II medical device recall Z-1152-2020
Ongoing recall by Respironics California, LLC, reported 2020-02-19, distributed nationwide. Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change
| Recall number | Z-1152-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Respironics California, LLC, Carlsbad, CA, United States |
| Recall initiated | 2019-09-11 |
| Classified | 2020-02-12 |
| Reported by FDA | 2020-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CL, CN, CO, DE, EC, ES, FI, FR, GB, GR, GT, HK, HR, ID, IL, IN, IS, IT, MX, MY, NL, OM, PE, PH, PL, PT, SA, SE, SG, TR, TW, VN, ZA |
| Quantity | 2,851 |
| Serial numbers | 100005249, 100007779, 100007982, 100008795, 100009556, 100010513, 100011641, 100015789, 100020831, 100021459, 100021751, 100023634, 100023729, 100026949, 100029508, 100034162, 100034395, 100066214, 100082340, 100246732, 100248301, 100250369, 100252951, 100254466, 100254552 and 475 more |
| Model numbers | 1053613, 1053614, 1053617 |
Product
Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614
Reason for recall
Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchscreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.
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-1152-2020. 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.