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Recall Observatory FDA recall evidence

Device product

Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP

Z-0046-2025

September 12, 2024

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 95398
Status
Ongoing
Classification
Class I
Quantity
10,957 units
Official record key
device-enforcement:Z-0046-2025

Official wording

Reason: The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.

Code information: UDI/DI 00887761978089 or 00815410020537, All Life2000 Ventilators with software version 06.08.00.00

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.