‘Cyber issue’ leads to FDA recall of Baxter respiratory gear
The Food and Drug Administration is warning that Life 2000 – an at-home ventilation system built by medical device maker Baxter – has been permanently recalled due to a cyber issue that could allow individuals with physical access to tamper with the gear’s life support settings.
Baxter in April began notifying at-home patients about an unspecified cyber problem with their Life 2000 equipment, urging patients to reach out to their healthcare provider for therapy replacement options.
Baxter describes the Life 2000 as a portable, lightweight “mask-free non-invasive ventilator that is designed to provide breathing support to patients at home … as they go about their activities of daily living.”
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