Welch Allyn Life2000 Ventilation System Recalled for Cybersecurity Vulnerability
Baxter Healthcare is recalling approximately 4,881 units of the Welch Allyn Life2000 Ventilation system worldwide due to a cybersecurity vulnerability discovered through internal testing. No injuries have been reported.
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: FDA Class I medical device recall with a cybersecurity vulnerability. While no injuries or deaths have been reported and the hazard was identified through internal testing, the FDA's Class I classification indicates serious potential risk to patient safety, warranting a minimum severity of 4.
Plain-English summary
Baxter Healthcare Corporation is recalling the Welch Allyn Life2000 Ventilation system due to a cybersecurity vulnerability discovered through internal testing. Approximately 4,881 units have been distributed worldwide.
Affected product codes include: BT-20-0002, BT-20-0002A, BT-20-0002AP, BT200007, BT-20-0007, BT200011, BT-20-0011, and RMS010118CP. Detailed serial numbers and UDI (Unique Device Identifier) codes for identifying affected units are documented in the recall notice.
No injuries or deaths have been reported. The U.S. Food and Drug Administration has classified this as a Class I recall, indicating a serious potential risk. Users of this ventilation system should contact Baxter Healthcare Corporation for information on affected units and necessary corrective actions.
The recalled product
- Product
- Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.
- Manufacturer
- Baxter Healthcare Corporation
- 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 (12)
- ALL SERIAL NUMBERS: 1) BT-20-0002
- UDI/DI 00815410020537 or 00887761978089
- 2) BT-20-0002A
- UDI/DI 00815410020537 of 00887761978089
- 3) BT-20-0002AP
- 4) BT200007
- UDI/DI 00815410020278 or 00887761978089
- 5) BT-20-0007
- 6) BT200011
- 7) BT-20-0011
- 8) RMS010118CP
- UDI/DI 00815410020537 or 00887761978089.
Distribution
Distribution scope not specified by the agency.
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