FDA Device recall Z-2074-2021
Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10
- FDA Device
- Class I
- ongoing
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class I recall of Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10 by Respironics California, citing 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 pres….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2074-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-06-18 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Respironics California |
| Distribution | US |
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
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.
Identifiers
| code_info | Model V60 Plus Ventilator: P/N 1138747 and 1137276; US System Serial Number/UDI Code: 100363973/ ; 100366525/ ; 1…Model V60 Plus Ventilator: P/N 1138747 and 1137276; US System Serial Number/UDI Code: 100363973/ ; 100366525/ ; 100366542/ ; 100371876/ (01)00884838090996(21)100371876; 100373102/ (01)00884838090996(21)100373102; 100374459/ (01)00884838090996(21)100374459; 100376350/ (01)00884838090996(21)100376350; 100377311/ (01)00884838090996(21)100377311; 100377324/ (01)00884838090996(21)100377324; 100380441/ (01)00884838090996(21)100380441; 100382407/ (01)00884838090996(21)100382407; 100382452/ (01)00884838090996(21)100382452; 100382461/ (01)00884838090996(21)100382461; 100384413/ (01)00884838090996(21)100384413; 100384748/ (01)00884838090996(21)100384748; 100385425/ (01)00884838090996(21)100385425; 100385428/ (01)00884838090996(21)100385428; 100385429/ (01)00884838090996(21)100385429; 100385447/ (01)00884838090996(21)100385447; 100385529/ (01)00884838090996(21)100385529; 100386081/ (01)00884838090996(21)100386081; 100386137/ (01)00884838090996(21)100386137; 100386179/ (0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2074-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.