510(k) K110213 ยท BSZ Gas-Machine, Anesthesia
GE DATEX-OHMEDA AISYS
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Jul 20, 2011 |
| Received | Jan 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110213
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2018 | GE Healthcare, LLC Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, Terminated |
BSZ | None listed |
| Nov 9, 2018 | GE Healthcare, LLC Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR U Terminated |
BSZ | None listed |
| Nov 9, 2018 | GE Healthcare, LLC Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN,
TOUCHSCREEN Terminated |
BSZ | None listed |
| Mar 15, 2016 | GE Medical Systems, LLC GE Healthcare, Aisys and Aisys CS2.
Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult). Terminated |
BSZ | None listed |
| Feb 17, 2016 | GE Medical Systems, LLC GE Healthcare, Aisys Carestation. Terminated |
BSZ | None listed |
| Jan 21, 2016 | GE Medical Systems, LLC GE Healthcare, Aisys, 1011-9000-000.
The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pe Terminated |
BSZ | None listed |
| Oct 15, 2013 | GE Healthcare, LLC GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom.
Intended for volume or pressure control ventilation. Terminated |
BSZ | None listed |
| Oct 15, 2013 | GE Healthcare, LLC GE Healthcare, Aisys, Amingo, Avance, and Avance CS2.
Intended for volume or pressure control ventilation. Terminated |
BSZ | None listed |
| Jun 3, 2013 | GE Healthcare, LLC Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850.
Intended to provide general inhalation anesthesia and ventilatory support. Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.