Recall Z-0681-2016— GE Medical Systems, LLC
Class II · Terminated
Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2015-12-15, terminated 2016-09-21. It names 3 FDA 510(k) clearances: K132530, K131945, K112722. Product: 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 pressure control ventilation. The Aisys is not suitable for use in a MRI environment.. 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..
- Recalling firm
- GE Medical Systems, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-15
- Terminated
- 2016-09-21
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
3 on FDA's record- K132530 — GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
- K131945 — GE DATEX-OHMEDA AVANCE CS2
- K112722 — GE DATEX-OHMEDA AVANCE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.