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Recall Observatory FDA recall evidence

Device product

Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP

Z-0887-2025

December 20, 2024

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 95842
Status
Ongoing
Classification
Class I
Quantity
1 unit
Official record key
device-enforcement:Z-0887-2025

Official wording

Reason: There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

Code information: UDI/DI 00887761978089 or 00815410020537, Serial Numbers: 122010001081

Distribution pattern: US, Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.