Recall Z-0885-2021— Respironics California, LLC

Name: FDA recall Z-0885-2021
Creator: U.S. Food and Drug Administration
Published: 2020-10-30

Class II · Terminated

Class II FDA medical device recall by Respironics California, LLC, initiated 2020-10-30, terminated 2024-09-19. It names one FDA 510(k) clearance: K082660. 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.. Reason: 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..

Recalling firm: Respironics California, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-10-30
Terminated: 2024-09-19
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K082660 — V60 VENTILATOR, MODEL V8000Respironics California, Inc.·cleared 2009-01-09

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 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.

Reason for recall

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.

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