FDA (Devices) recall action 86697

Respironics California, LLC recalled 16 products on 2021-02-03

The FDA (Devices) publishes a recall like this one as 16 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 16 pages.

Products: 16
Announced: 2021-02-03
Critical: 0
Units: 27,071

Why these products were recalled

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

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

1–16 of 16

HighFDA (Devices)··2021-02-03
Philips Respironics V60 Ventilator Recall for Navigation Ring Issues
Respironics is recalling 3,752 V60 Ventilators worldwide due to potential navigation ring malfunctions that may cause erratic parameter changes or inoperability.
Product
Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Distribution
2 states
HighFDA (Devices)··2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects
Respironics is recalling 3,213 V60 Ventilators worldwide due to navigation ring issues that may cause erratic parameter changes or inoperability.
Product
Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Distribution
2 states
HighFDA (Devices)··2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring and Liquid Ingress Issues
Respironics is recalling 934 V60 Ventilators worldwide due to potential navigation ring malfunctions and liquid ingress risks.
Product
Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Distribution
2 states
HighFDA (Devices)··2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects
Respironics is recalling 9,856 V60 Ventilators worldwide due to navigation ring issues that may cause erratic parameter changes or inoperability.
Product
Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Distribution
2 states
HighFDA (Devices)··2021-02-03
Philips Respironics V60 Ventilator Recall for Navigation Ring Defects
Respironics is recalling three V60 ventilators because the navigation ring may malfunction or cause erratic parameter changes.
Product
Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Distribution
2 states
HighFDA (Devices)··2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring Defect
Respironics is recalling 10,291 V60 ventilators worldwide due to a navigation ring that may fail or cause erratic parameter changes.
Product
Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Distribution
2 states
HighFDA (Devices)··2021-02-03
Philips Respironics V60 Plus Ventilator Recall Due to Navigation Ring Malfunction
The FDA is recalling the Philips Respironics V60 Plus Ventilator because its navigation ring may become inoperative or operate intermittently, potentially causing ventilator parameter values to change erratically during setup or adjustment.
Product
Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Distribution
2 states
HighFDA (Devices)··2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects
Respironics is recalling 834 V60 ventilators because the navigation ring may malfunction or cause erratic parameter changes.
Product
Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Distribution
2 states
HighFDA (Devices)··2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects
Respironics is recalling 2,137 V60 Ventilators because the navigation ring may malfunction or cause erratic parameter changes.
Product
Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Distribution
2 states
HighFDA (Devices)··2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring Defect
Respironics is recalling V60 Ventilators because the navigation ring may malfunction or cause erratic parameter changes.
Product
Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Distribution
2 states
HighFDA (Devices)··2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects
Respironics is recalling 216 V60 Ventilators because the navigation ring may fail or cause erratic parameter changes.
Product
Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Distribution
2 states
HighFDA (Devices)··2021-02-03
Philips Respironics V680 Ventilator Recalled for Navigation Ring Defects
Respironics is recalling 3,453 V680 ventilators worldwide because the navigation ring may fail or cause erratic parameter changes.
Product
Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Distribution
2 states
HighFDA (Devices)··2021-02-03
Philips Respironics V60 Ventilator Recall for Navigation Ring Defects
Respironics is recalling V60 ventilators because the navigation ring may fail or cause erratic parameter changes.
Product
Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Philips Respironics V60 Ventilator Part Number U105
Category
Distribution
2 states
HighFDA (Devices)··2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects
Respironics is recalling 534 V60 Ventilators worldwide due to navigation ring malfunctions that may cause erratic parameter changes or inoperability.
Product
Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Distribution
2 states
HighFDA (Devices)··2021-02-03
Philips Respironics V60 Plus Ventilator Recalled for Navigation Ring Issues
Respironics is recalling V60 Plus ventilators because the navigation ring may fail or cause erratic parameter changes.
Product
Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Distribution
2 states
HighFDA (Devices)··2021-02-03
Philips Respironics V60 Ventilator Recalled for Navigation Ring and Liquid Ingress Issues
Respironics is recalling V60 Ventilators because the navigation ring may malfunction or cause erratic parameter changes, and liquid may enter the device.
Product
Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Category
Distribution
2 states