FDA recall Z-0915-2020

Product

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.

Distribution

U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT

Key facts

Status

Completed

Initiation date

2019-12-12

Report date

2020-02-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bella Vista, N/A, Australia

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0915-2020