Baxter Healthcare Corporation is recalling 9,055 units of the Welch Allyn Life2000 Ventilation system and its accompanying compressors due to a cybersecurity vulnerability discovered during internal testing. This vulnerability involves a software weakness that could potentially allow an unauthorized person to access the device. The recall affects several models of the ventilation system and compressor units distributed worldwide.
The cybersecurity vulnerability could potentially allow an unauthorized user to gain access to the device settings. This could result in unauthorized changes to ventilation parameters or the device being disabled, which poses a risk of serious injury or death to patients who depend on the ventilator for breathing support. No injuries or incidents have been reported to date.
Correction or replacement of cybersecurity firmware.
Quantity: 4881 units. Affected codes: BT-20-0002 (UDI 00815410020537 or 00887761978089); BT-20-0002A (UDI 00815410020537 or 00887761978089); BT-20-0002AP (UDI 00815410020537 or 00887761978089); BT200007 (UDI 00815410020278 or 00887761978089); BT-20-0007 (UDI 00815410020278 or 00887761978089); BT200011 (UDI 00815410020537 or 00887761978089); BT-20-0011 (UDI 00815410020537 or 00887761978089); RMS010118CP (UDI 00815410020537 or 00887761978089).
Quantity: 4174 units. Affected codes: BT-80-0004 (UDI 00887761978041, 00815410020292, or 00887761978072); BT-80-0004A (UDI 00887761978041, 00815410020292, or 00887761978072); BT-80-0008 (UDI 00887761976283); BT-80-0008A (UDI 00887761976283); RMS010093CP (UDI 00887761978041, 00815410020537, or 00815410020292).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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