There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
Reason for recall: There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator. Distribution: Nationwide Quantity: 8 units Lot/code info: a) REF BT200011, UDI 00887761978089, Serial Numbers: L190606-014, L191011-040, L200127-015, L200204-013; b) REF BT-20-0011, UDI 00887761978089, Serial Numbers: L200226-012, L200226-013, L200226-015
00887761978089
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.