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

Is my product affected?

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

• UPC 20160123307
• UPC 22171057208

Check against the official notice below — it lists the full affected range.

What happened

ResMed Ltd. is recalling 69 ResMed Stellar non-invasive and invasive ventilators (Models 100 and 150) distributed in Pennsylvania, Massachusetts, Virginia, Tennessee, Connecticut, Illinois, Georgia, Florida, and Montana. The recall involves ventilators with serial numbers ranging from 20160123307 to 22171057208. The devices pose a hazard when a combination of software and component failure occurs in units with a failed electronic component that have been stored without AC power for more than 36 hours, causing complete battery depletion. When these affected ventilators are reconnected to AC power and power on automatically without the user pressing the power switch, the audible alarms and alarm buzzer may not operate properly.

The record does not specify a remedy or actions consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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 Quantity: 69 Lot/code info: Serial Number Range: 20160123307 to 22171057208

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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