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Recall Observatory FDA recall evidence

Device 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.

Z-1726-2025

April 07, 2025

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 96611
Status
Ongoing
Classification
Class I
Quantity
4174 units
Official record key
device-enforcement:Z-1726-2025

Official wording

Reason: A cybersecurity vulnerability was discovered through internal testing.

Code information: ALL SERIAL NUMBERS: 1) BT-80-0004, UDI/DI 00887761978041 or 00815410020292 or 00887761978072; 2) BT-80-0004A, UDI/DI 00887761978041 or 00815410020292 or 00887761978072; 3) BT-80-0008, UDI/DI 00887761976283; 4) BT-80-0008A, UDI/DI 00887761976283; 5) RMS010093CP, UDI/DI 00887761978041 or 00815410020537 or 00815410020292.

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    cybersecurity vulnerability