Recall Z-1137-2021— Respironics California, LLC

Name: FDA recall Z-1137-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-06

Class II · Ongoing

Class II FDA medical device recall by Respironics California, LLC, initiated 2021-01-06. It names one FDA 510(k) clearance: K082660. Product: PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.. Reason: Due to unqualified "design verification" batteries being shipped to customers..

Recalling firm: Respironics California, LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-01-06
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 BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Reason for recall

Due to unqualified "design verification" batteries being shipped to customers.

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