Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number 1053617

Recall date

January 24, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0662-2022

FDA classification

Class I

Brand / firm

Respironics California, LLC

Sold / distributed

U.S.: AR, CA, FL, GA, IN, LA, MD, MO, NY, PA, SC, TN and TX. O.U.S. N/A

Why it was 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).

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Philips Respironics V60 Ventilator Part Number 1053617