FDA Device recall Z-0010-2014
GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom
- FDA Device
- Class I
- terminated
- Published 2013-10-23
On 2013-10-23 the FDA classified a Class I recall of GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom by Ge Healthcare, citing GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstr¿m ventilator and the Aespire View, Aisys, and Avanc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0010-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-08-28 |
| Published | 2013-10-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
Reason
GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstr¿m ventilator and the Aespire View, Aisys, and Avance anesthesia machines. As a result of a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect button presses. This may result in the inability to access certain menu functions wh
Identifiers
| code_info | Mfg Lot or Serial # APHS00701 APHS00802 APHS00729 APHS00730 APHS00700 APHS00692 APHS00932 APHS00886 APHS00861…Mfg Lot or Serial # APHS00701 APHS00802 APHS00729 APHS00730 APHS00700 APHS00692 APHS00932 APHS00886 APHS00861 APHS00865 APHS00866 APHS00867 APHS00868 APHS00887 APHS00888 APHS00860 APHS00881 70138420 - 1 APHS00844 APHS00711 APHS00712 5324664 - 1 APHS00703 APHS00704 5328496 - 1 APHS00690 APHS00719 APHS00720 APHS00722 APHS00723 APHS00828 APHS00834 APHS00835 APHS00836 APHS00843 APHS00809 APHS00854 APHS00855 APHS00856 APHS00857 APHS00858 APHS00691 APHS00702 APHS00705 APHS00721 APHS00807 APHS00808 APHS00811 APHS00685 APHS00695 APHS00696 APHS00697 APHS00698 APHS00699 APHS00805 APHS00806 APHS00812 APHS00810 APHS00864 APHS00643 APHS00644 APHS00645 APHS00646 APHS00647 APHS00648 APHS00649 APHS00650 APHS00651 APHS00652 APHS00653 APHS00654 APHS00655 APHS00656 APHS00657 APHS00666 APHS00667 APHS00731 APHS00732 APHS00733 APHS00734 APHS00735 APHS00736 APHS00737 APHS00738 APHS00739 APHS00740 APHS00741 APHS00742 APHS |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0010-2014%22
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