PlainRecalls
FDA Devices Critical Class I Ongoing

Philips Respironics V60 Ventilator Part Number 1053617

Reported: March 9, 2022 Initiated: January 24, 2022 #Z-0662-2022

Product Description

Philips Respironics V60 Ventilator Part Number 1053617

Reason for Recall

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).

Details

Units Affected
16 systems
Distribution
U.S.: AR, CA, FL, GA, IN, LA, MD, MO, NY, PA, SC, TN and TX. O.U.S. N/A
Location
Carlsbad, CA

Frequently Asked Questions

What product was recalled?
Philips Respironics V60 Ventilator Part Number 1053617. Recalled by Respironics California, LLC. Units affected: 16 systems.
Why was this product recalled?
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).
Which agency issued this recall?
This recall was issued by the FDA Devices on March 9, 2022. Severity: Critical. Recall number: Z-0662-2022.