FDA Device recall Z-0677-2016
GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000
- FDA Device
- Class II
- terminated
- Published 2016-01-27
On 2016-01-27 the FDA classified a Class II recall of GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000 by Ge Medical Systems, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0677-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-15 |
| Published | 2016-01-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Medical Systems |
| Distribution | US |
Product
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 volume or pressure control ventilation.
Reason
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.
Identifiers
| code_info | AESPIRE 7900 ANCU00662 ANCU00813 ANCU00814 ANCU00815 ANCU00816 ANCU00817 ANCU00818 ANCU00597 ANCU00598 ANCU…AESPIRE 7900 ANCU00662 ANCU00813 ANCU00814 ANCU00815 ANCU00816 ANCU00817 ANCU00818 ANCU00597 ANCU00598 ANCU00599 ANCU00600 ANCU00601 ANCU00671 ANCU00672 ANCU00673 ANCU00676 ANCU00678 ANCU00683 ANCU00830 ANCU00832 ANCU00870 ANCU00871 ANCU00872 ANCU00873 ANCU00874 ANCU00875 ANCU00629 ANCU00630 ANCU00638 ANCU00639 ANCU00640 ANCU00641 ANCU00806 ANCU00604 ANCU00684 ANCU00836 ANCU00837 ANCU00839 ANCU00786 ANCU00680 ANCU00681 ANCU00625 ANCU00626 ANCU00677 ANCU00618 ANCU00619 ANCU00620 ANCU00602 ANCU00603 ANCU00448 ANCU00449 ANCU00770 ANCU00771 ANCU00865 ANCU00866 ANCU00867 ANCU00803 ANCU00605 ANCU00663 ANCU00682 ANCU00685 ANCU00458 ANCU00459 ANCU00831 ANCU00653 ANCU00820 ANCU00591 ANCU00592 ANCU00586 ANCU00583 ANCU00584 ANCU00585 ANCU00825 ANCU00593 ANCU00664 ANCU00838 ANCU00433 ANCU00679 ANCU00555 ANCU00456 ANCU00457 ANCU00590 ANCU00661 ANCU00669 ANCU00670 ANCU00674 ANCU00819 ANCU00807 ANCU00808 ANCU0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0677-2016%22
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