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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 9 of 9 Results
510(K) Number: K110213
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Product Description
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GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pres... 1 10/15/2013 GE Healthcare, LLC
GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ven... 1 10/15/2013 GE Healthcare, LLC
Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPG... 2 11/09/2018 GE Healthcare, LLC
Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE... 2 11/09/2018 GE Healthcare, LLC
Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGL... 2 11/09/2018 GE Healthcare, LLC
GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventila... 2 04/22/2016 GE Medical Systems, LLC
GE Healthcare, Aisys Carestation. 2 04/13/2016 GE Medical Systems, LLC
GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to p... 2 01/21/2016 GE Medical Systems, LLC
Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended ... 2 06/03/2013 GE Healthcare, LLC
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