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
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Nov 3, 2017 |
| Received | Jul 6, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172045
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Datex-Ohmeda, Inc. Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 Open, Classified |
BSZ | None listed |
| Sep 16, 2026 | Datex-Ohmeda, Inc. Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000 Open, Classified |
BSZ | None listed |
| Sep 16, 2026 | Datex-Ohmeda, Inc. Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000 Open, Classified |
BSZ | None listed |
| Sep 16, 2026 | Datex-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 |
BSZ | None listed |
| Oct 18, 2024 | Datex-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 |
BSZ | None listed |
| Oct 18, 2024 | Datex-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 |
BSZ | None listed |
| Oct 18, 2024 | Datex-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 |
BSZ | None listed |
| Oct 18, 2024 | Datex-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 |
BSZ | None listed |
| Oct 18, 2024 | Datex-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 |
BSZ | None listed |
| Oct 18, 2024 | Datex-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 |
BSZ | None listed |
| Oct 18, 2024 | Datex-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 |
BSZ | None listed |
| Oct 18, 2024 | Datex-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 |
BSZ | None listed |
| Oct 18, 2024 | Datex-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 |
BSZ | None listed |
| Jul 19, 2022 | GE 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 |
BSZ | None listed |
| May 27, 2022 | GE 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 |
BSZ | None listed |
| Apr 25, 2022 | GE Healthcare, LLC Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured
on or after April 1, 2019 Open, Classified |
BSZ | None listed |
| Apr 25, 2022 | GE 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 |
BSZ | None listed |
| Aug 2, 2021 | GE 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 |
BSZ | None listed |
| Aug 2, 2021 | GE 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 |
BSZ | None listed |
| Sep 17, 2020 | GE 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 |
BSZ | None listed |
| Sep 17, 2020 | GE 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 |
BSZ | None listed |
| Sep 17, 2020 | GE 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 |
BSZ | None listed |
| Sep 17, 2020 | GE Healthcare, LLC 9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only. Open, Classified |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.