Welch Allyn Life2000 Compressor Recall Due to Cybersecurity Vulnerability
Baxter Healthcare Corporation is recalling approximately 4,174 Welch Allyn Life2000 Compressor units (FDA Class I) due to a cybersecurity vulnerability discovered through 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: FDA Class I classification mandates a minimum severity level of Severe. Although no patient incidents have been reported, the cybersecurity vulnerability in this medical device poses a potential risk to device functionality and security.
Plain-English summary
Baxter Healthcare Corporation is recalling the Welch Allyn Life2000 Compressor due to a cybersecurity vulnerability identified during internal testing. This FDA Class I recall affects approximately 4,174 units that were distributed worldwide.
The cybersecurity vulnerability was discovered as part of the manufacturer's internal testing procedures. Affected customers should contact Baxter Healthcare Corporation for information on remediation and the status of this recall.
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
- 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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