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Respironics California Recalls
53 recalls on record · September 12, 2012 to April 27, 2022 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 27, 2022Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United State
Hazard: 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.
April 27, 2022Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
Hazard: 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.
April 27, 2022Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709
Hazard: 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.
March 9, 2022Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Plus Ventilator Part Number 1138747
Hazard: A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
March 9, 2022Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number 1053617
Hazard: A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
July 28, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator
Hazard: 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.
July 28, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is a
Hazard: 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.
March 3, 2021Medical DevicesFDA
Respironics California, LLC recalls PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is inte
Hazard: Due to unqualified "design verification" batteries being shipped to customers.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinatio
Hazard: 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.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinat
Hazard: 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.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combi
Hazard: 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.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinatio
Hazard: 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.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combi
Hazard: 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.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinatio
Hazard: 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.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinatio
Hazard: 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.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinati
Hazard: 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.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinati
Hazard: 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.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinatio
Hazard: 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.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinatio
Hazard: 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.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinatio
Hazard: 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.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinatio
Hazard: 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.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinatio
Hazard: 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.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinatio
Hazard: 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.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinatio
Hazard: 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.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinatio
Hazard: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinati
Hazard: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinat
Hazard: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combi
Hazard: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinatio
Hazard: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
February 3, 2021Medical DevicesFDA
Respironics California, LLC recalls Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combi
Hazard: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.