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Recall Observatory FDA recall evidence

Device product

Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002

Z-0884-2025

December 20, 2024

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 95842
Status
Ongoing
Classification
Class I
Quantity
187 units
Official record key
device-enforcement:Z-0884-2025

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 00887761978201, Serial Numbers: 124080000663, 124020000164, 124020000165, 124020000166, 124020000167, 124020000168, 124020000169, 124020000170, 124020000171, 124020000172, 124020000173, 124020000174, 124020000175, 124020000176, 124080000659, 124080000661, 124080000662, 124080000666, 124080000667, 124080000668, 124080000669, 123420000499, 123490000931, 124010000910, 124020000163, 124080000670, 124080000672, 124080000673, 124080000675, 124080000677, 124080000678, 124080000679, 124080000715, 124080000716, 124080000718, 124080000733, 124080000735, 124080000772, 124080000784, 124080000854, 124080000855, 124080000856, 124080000857, 124080000863, 124080000865, 124080000919, 124080000920, 124080000921, 124080000922, 124080000923, 124080000924, 124080000925, 124080000926, 124080001290, 124080001367, 124080001388, 124080001409, 124080001594, 124080001596, 124080001601, 124080001602, 124080001603, 124080001604, 124080001605, 124080001606, 124080001608, 124080001609, 124080001610, 124080001612, 124080001614, 124140000062, 124140000063, 124140000065, 124140000067, 124140000068, 124140000069, 124140000070, 124140000123, 124140000125, 124140000126, 124140000127, 124140000401, 124140000402, 124140000403, 124140000404, 124140000405, 124140000636, 124140000637, 124140000638, 124140000668, 124140000671, 124140000672, 124140000675, 124140000677, 124140000679, 124140000681, 124140000683, 124140000684, 124140000686, 124140000687, 124140000688, 124140001005, 124140001014, 124140001187, 124140001191, 124140001195, 124140001201, 124140001203, 124160001584, 124170000747, 124170000749, 124170000804, 124170000828, 124170000832, 124170001158, 124170001159, 124170001161, 124170001162, 124170001163, 124170001166, 124170001171, 124170001172, 124200000070, 124200000071, 124200000072, 124200000073, 124200000074, 124200000076, 124200000077, 124200000078, 124200000079, 124200000080, 124200000081, 124200000083, 124200000084, 124200002473, 124200002474, 124200002475, 124200002476, 124200002478, 124200002479, 124200002480, 124200002481, 124200002482, 124200002485, 124200002486, 124200002489, 124200002490, 124200002491, 124200002492, 124200002493, 124200002494, 124200002495, 124200002496, 124200002497, 124200002498, 124200002499, 124200002500, 124200002501, 124200002502, 124200002503, 124200002504, 124200002505, 124200002506, 124200002507, 124200002508, 124200002509, 124250000491, 124250000492, 124250000493, 124250000494, 124250000495, 124250000496, 124250000497, 124250000498, 124250000499, 124250000500, 124250000533, 124250000534, 124250000535, 124250000536, 124250000537, 124250000538, 124260000558, 124260001171, 124280000585, 124280000741.

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.

Field note

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