Recall Z-0915-2020— ResMed Ltd.

Name: FDA recall Z-0915-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-12

Class I · Completed

Class I FDA medical device recall by ResMed Ltd., initiated 2019-12-12. It names one FDA 510(k) clearance: K122715. Product: ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150. Reason: Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power without pressing the power switch..

Recalling firm: ResMed Ltd.
Classification: Class I
Status: Completed
Initiated: 2019-12-12
Firm location: Bella Vista, N/A, Australia

510(k) clearances named in this recall

1 on FDA's record

K122715 — STELLAR 150Resmed Germany, Inc.·cleared 2013-06-17

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

ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150

Reason for recall

Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power without pressing the power switch.

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