Recall Z-0010-2014— GE Healthcare, LLC
Class I · Terminated
Class I FDA medical device recall by GE Healthcare, LLC, initiated 2013-08-28, terminated 2015-01-30. It names 5 FDA 510(k) clearances: K123125, K122445, K112722 and 2 more. 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.
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-08-28
- Terminated
- 2015-01-30
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
5 on FDA's record- K123125 — GE DATEX-OHMEDA AVANCE CS2
- K122445 — AESPIRE 7900, AESPIRE VIEW
- K112722 — GE DATEX-OHMEDA AVANCE
- K111116 — ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
- K110213 — GE DATEX-OHMEDA AISYS
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, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.