Philips Respironics V60 Plus Ventilator with Software Versions 3 — Class I medical device recall Z-2074-2021
Ongoing recall by Respironics California, LLC, reported 2021-07-28, distributed nationwide. It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), tha
| Recall number | Z-2074-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Respironics California, LLC, Carlsbad, CA, United States |
| Recall initiated | 2021-06-18 |
| Classified | 2021-07-21 |
| Reported by FDA | 2021-07-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, CA, CH, CL, CN, CO, CZ, DE, DK, ES, FI, FR, GB, GR, HK, ID, IE, IN, IS, IT, JO, KE, KW, LB, LV, MA, MT, MX, MY, NG, NL, NO, NZ, PH, PL, PT, QA, SA, SE, SG, SI, TH, ZA |
| Quantity | 23,115 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838089280, 00884838090996 |
| Model numbers | V60 |
Product
Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.
Reason for recall
It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe 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-2074-2021. 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.