Device recall: ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
Class I FDA enforcement event 84551. Recall start date: . Status in the FDA record: Completed.
Reason for recall, in the words of FDA
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.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
ResMed Ltd. started this device recall on 12 Dec 2019. The firm address in the FDA record is in Bella Vista. FDA put the recall in Class I. FDA event 84551 has 1 product record. The first FDA enforcement report date is 12 Feb 2020. The record gives the status Completed.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT
Recalling firm
ResMed Ltd., Bella Vista, N/A, Australia.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0915-2020 | ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 | 69 | Class I | Completed | 12 Feb 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class I
- 6%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 25 Jun 2026 | Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory s | Device | Class I | 1 |
| 20 Nov 2023 | AirFit N10 Nasal Masks and User Guide | Device | Class I | 7 |
| 13 Sep 2023 | Astral 100 and Astral 150 ventilators | Device | Class I | 1 |
| 5 May 2015 | Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator. | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0915-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 84551. https://recallregister.com/fda/i/84551/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT
- What quantity of product is in FDA event 84551?
- The FDA record gives this quantity:
69
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 6% of the 968 device events that started in 2019 are in Class I.