Z-0915-2020 Class I
FDA device recall Z-0915-2020 was initiated by ResMed Ltd. on Dec 12, 2019 and is designated Class I. 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… Affected quantity: 69.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 12, 2020
- Initiation Date
- Dec 12, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69
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.
Distribution Pattern
U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT
Code Information
Serial Number Range: 20160123307 to 22171057208
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0915-2020
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026