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.
Reason for recall: 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. Distribution: US, Nationwide Distribution Quantity: 187 units Lot/code info: 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, 12414
00887761978201, 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.