Recall Z-0009-2014— GE Healthcare, LLC
Class I · Terminated
Class I FDA medical device recall by GE Healthcare, LLC, initiated 2013-09-16, terminated 2015-10-01. It names 3 FDA 510(k) clearances: K123125, K112722, K110213. Product: GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.. Reason: GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessiv.
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-09-16
- Terminated
- 2015-10-01
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
3 on FDA's recordK-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, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessiv
Data sourced from openFDA. This site is unofficial and independent of the FDA.