Welch Allyn Life2000 Compressor recalled for cybersecurity vulnerability
Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Compressor units due to a cybersecurity vulnerability discovered during internal testing.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which per the rubric requires a minimum score of 4. The cybersecurity vulnerability in a life-critical medical device presents significant risk of harm.
Plain-English summary
Baxter Healthcare Corporation is recalling the Welch Allyn Life2000 Compressor, a medical device distributed worldwide. The recall affects approximately 4,174 units with product codes BT-80-0004, BT-80-0004A, BT-80-0008, BT-80-0008A, and RMS010093CP.
A cybersecurity vulnerability was discovered through internal testing of the device. The FDA has classified this as a Class I recall, indicating the device has the potential to cause serious injury or death.
Users of the Welch Allyn Life2000 Compressor should contact Baxter Healthcare Corporation for instructions regarding the vulnerability and appropriate remedial action. Healthcare facilities and individuals with affected units should follow the manufacturer's guidance.
The recalled product
- Product
- Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Compressor
- Hazard
- cybersecurity-vulnerability
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 (8)
- ALL SERIAL NUMBERS: 1) BT-80-0004
- UDI/DI 00887761978041 or 00815410020292 or 00887761978072
- 2) BT-80-0004A
- 3) BT-80-0008
- UDI/DI 00887761976283
- 4) BT-80-0008A
- 5) RMS010093CP
- UDI/DI 00887761978041 or 00815410020537 or 00815410020292.
Distribution
Distribution scope not specified by the agency.
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