ResMed Stellar Ventilators Recalled for Potential Alarm Failure
ResMed is recalling 69 Stellar ventilators because a software and component failure may prevent audible alarms from operating properly.
The agency’s classification
FDA (Devices): Class I
Class I is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies this as an FDA Class I recall. Per the rubric, FDA Class I recalls are classified as Severe (score 4) or Critical (score 5). Since no deaths or serious injuries are reported in the text, the score is 4.
Plain-English summary
ResMed Ltd. is recalling 69 units of the ResMed Stellar Non-invasive/invasive ventilators, Models 100 and 150. The recall involves serial numbers ranging from 20160123307 to 22171057208. These devices were distributed in Pennsylvania, Massachusetts, Virginia, Tennessee, Connecticut, Illinois, Georgia, Florida, and Montana.
The recall is due to a combination of software and a component failure that may cause audible alarms not to operate properly. Specifically, the alarm buzzer may not work for ventilators that have a failed electronic component, are stored without AC power connected for more than 36 hours leading to full battery depletion, and power on automatically when connected to AC power without pressing the power switch.
This is an FDA Class I recall. Consumers should contact ResMed for instructions on how to address the issue.
The recalled product
- Product
- ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
- Manufacturer
- ResMed Ltd.
- Category
- Medical Device — Ventilators
- Hazard
- Affected units
- 69
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number Range: 20160123307 to 22171057208
Distribution
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