FDA Device recall Z-2073-2021
Philips Respironics V60 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 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-2073-2021 |
| 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 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 Ventilator: P/N 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076716, 1137292 US Syst…Model V60 Ventilator: P/N 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076716, 1137292 US System Serial Number/UDI Code: 100351272 (01)00884838020054(21)100351272 100006691 100193211 100220566 (01)00884838020054(21)100220566 100313757 (01)00884838020054(21)100313757 100313412 (01)00884838020054(21)100313412 100080135 100081569 100110187 100121703 100013472 100230650 (01)00884838020054(21)100230650 100374411 (01)00884838020054(21)100374411 100054305 100068863 100188390 100181283 100030036 100030039 100030046 100030040 100043349 100030041 100037246 201029401 (01)00884838020054(21)201029401 100278366 (01)00884838020054(21)100278366 100088340 100131320 201030489 (01)00884838020054(21)201030489 100057026 100074563 201005638 201001514 100027860 201005635 100154662 100056752 100130449 100154846 100078004 100055123 100191452 100077709 100015080 100191788 100129710 100028046 100077079 |
|---|
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-2073-2021%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.