Recall Z-0663-2022— Respironics California, LLC

Name: FDA recall Z-0663-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-24

Class I · Ongoing

Class I FDA medical device recall by Respironics California, LLC, initiated 2022-01-24. It names one FDA 510(k) clearance: K102985. Product: Philips Respironics V60 Plus Ventilator Part Number 1138747. Reason: 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)..

Recalling firm: Respironics California, LLC
Classification: Class I
Status: Ongoing
Initiated: 2022-01-24
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K102985 — V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONSRespironics, Inc.·cleared 2011-04-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Philips Respironics V60 Plus Ventilator Part Number 1138747

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.