Device recall: GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire…

Class II FDA enforcement event 72943. Recall start date: 15 Dec 2015. Status in the FDA record: Terminated. Termination date: 21 Sep 2016.

Reason for recall, in the words of FDA

The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

GE Medical Systems, LLC started this device recall on 15 Dec 2015. The firm address in the FDA record is in Waukesha, WI. FDA put the recall in Class II. FDA event 72943 has 6 product records. The first FDA enforcement report date is 27 Jan 2016. The record gives the status Terminated, with the termination date 21 Sep 2016.

FDA enforcement report The 6 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - US (nationwide including PR except NH, VT, & WY. Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA,…

Recalling firm

GE Medical Systems, LLC, Waukesha, WI.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

6 product records in the event.

FDA event 72943: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0677-2016	GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for…	1081	Class II	Terminated	27 Jan 2016
Z-0678-2016	GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures.	2	Class II	Terminated	27 Jan 2016
Z-0679-2016	GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The Aestiva/5 MRI…	84	Class II	Terminated	27 Jan 2016
Z-0680-2016	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, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use…	13	Class II	Terminated	27 Jan 2016
Z-0681-2016	GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or…	2627	Class II	Terminated	27 Jan 2016
Z-0682-2016	Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000 ASSY-MSN, VENT ENGINE ASSY AESPIRE 7900 1009-8423-000 ASSY-MSN, VENT ENGINE ASSY, AESTIVA 7900 MRI 1503-8102-000 ASSY-MSN, VLV ASSY DR GAS CHK BCG, Manufacturing assembly - Buy 1503-3006-000…	240	Class II	Terminated	27 Jan 2016

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2015: 1,153
Share of these events in Class II: 91%
Product records in this event: 6Median of the firm: 3
Events of the firm on the register: 42

Other events of the firm

Other FDA enforcement events of GE Medical Systems, LLC
Initiated	Product (first record)	Type	Class	Records
5 Jun 2026	Optima XR200amx, Mobile Digital-Ready Radiographic System	Device	Class II	3
1 May 2026	Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models	Device	Class II	3
20 Apr 2026	Allia IGS 3 Pulse angiographic X-ray system	Device	Class II	5
26 Mar 2026	Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300	Device	Class II	7
3 Feb 2026	Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E8	Device	Class II	1
30 Jan 2026	Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including	Device	Class II	3
24 Oct 2025	Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography	Device	Class II	1
18 Sep 2025	LOGIQ P10 series with software version R4.5.7 Model Number 5877534	Device	Class II	3
22 Aug 2025	MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Nu	Device	Class II	1
2 Jul 2025	GE HealthCare OEC 9800.	Device	Class II	2

GE Medical Systems, LLC: all 42 events

Official channels

FDA enforcement report Z-0677-2016The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 72943. https://recallregister.com/fda/ii/72943/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - US (nationwide including PR except NH, VT, & WY. Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA,…
What quantity of product is in FDA event 72943?: The event has 6 product records. The first record gives this quantity: 1081
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2015 have the same class?: 91% of the 1,153 device events that started in 2015 are in Class II.