The Recall Desk

FDA (Devices) recall action 89767

Respironics California, LLC recalled 3 products on 2022-04-27

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2022-04-27
Critical
0
Units
99,283

Why these products were recalled

Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • SevereFDA (Devices)··2022-04-27

    Philips Respironics V60 Ventilator Recalled Due to Electrical Circuit Defect

    Philips Respironics V60 ventilators are recalled due to an internal electrical circuit defect that may cause the device to stop operating. Approximately 87,138 units worldwide are affected.

    Product
    Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)
    Category
    Distribution
    50 states
  • SevereFDA (Devices)··2022-04-27

    Philips Respironics V680 Ventilator May Stop Operating Due to Electrical Fault

    Philips Respironics V680 Ventilators may stop operating due to an internal electrical circuit fault. Units were distributed worldwide and across the United States.

    Product
    Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
    Category
    Distribution
    50 states
  • SevereFDA (Devices)··2022-04-27

    Philips Respironics V60 Plus Ventilator Recalled for Electrical Circuit Failure Risk

    Philips Respironics V60 Plus Ventilators are recalled for an internal electrical circuit defect that could cause the device to stop operating. Approximately 12,145 units were affected worldwide.

    Product
    Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
    Category
    Distribution
    50 states