ClearanceBrief
510(k) K172045 ยท BSZ Gas-Machine, Anesthesia

Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2

ApplicantDatex-Ohmeda, Inc., Madison WI, US
DecisionSubstantially Equivalent, Nov 3, 2017
ReceivedJul 6, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K172045

DateFirm and productCodeLinked 510(k)
Sep 16, 2026Datex-Ohmeda, Inc.
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
Open, Classified
BSZNone listed
Sep 16, 2026Datex-Ohmeda, Inc.
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Open, Classified
BSZNone listed
Sep 16, 2026Datex-Ohmeda, Inc.
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Open, Classified
BSZNone listed
Sep 16, 2026Datex-Ohmeda, Inc.
Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000-000-S, 5700665
Open, Classified
BSZNone listed
Oct 18, 2024Datex-Ohmeda, Inc.
Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and a
Open, Classified
BSZNone listed
Oct 18, 2024Datex-Ohmeda, Inc.
Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified
Open, Classified
BSZNone listed
Oct 18, 2024Datex-Ohmeda, Inc.
Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualifie
Open, Classified
BSZNone listed
Oct 18, 2024Datex-Ohmeda, Inc.
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualifie
Open, Classified
BSZNone listed
Oct 18, 2024Datex-Ohmeda, Inc.
Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in t
Open, Classified
BSZNone listed
Oct 18, 2024Datex-Ohmeda, Inc.
Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals
Open, Classified
BSZNone listed
Oct 18, 2024Datex-Ohmeda, Inc.
Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in th
Open, Classified
BSZNone listed
Oct 18, 2024Datex-Ohmeda, Inc.
Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified i
Open, Classified
BSZNone listed
Oct 18, 2024Datex-Ohmeda, Inc.
Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due
Open, Classified
BSZNone listed
Jul 19, 2022GE Healthcare, LLC
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
Terminated
BSZNone listed
May 27, 2022GE Healthcare, LLC
GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
Open, Classified
BSZNone listed
Apr 25, 2022GE Healthcare, LLC
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
Open, Classified
BSZNone listed
Apr 25, 2022GE Healthcare, LLC
Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anesthesia devices
Open, Classified
BSZNone listed
Aug 2, 2021GE Healthcare, LLC
Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF
Open, Classified
BSZNone listed
Aug 2, 2021GE Healthcare, LLC
Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Carestation, S/5 Protiva Conf
Open, Classified
BSZNone listed
Sep 17, 2020GE Healthcare, LLC
Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability t
Open, Classified
BSZNone listed
Sep 17, 2020GE Healthcare, LLC
GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The de
Open, Classified
BSZNone listed
Sep 17, 2020GE Healthcare, LLC
GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The d
Open, Classified
BSZNone listed
Sep 17, 2020GE Healthcare, LLC
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
Open, Classified
BSZNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.