Recall Z-1443-2013— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2013-05-14, terminated 2014-03-12. It names 5 FDA 510(k) clearances: K123125, K122445, K112722 and 2 more. Product: Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support.. Reason: GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems. Reusable CO2 absorbent canisters accessories may not seal properly..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-14
- Terminated
- 2014-03-12
- 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
- K110213 — GE DATEX-OHMEDA AISYS
- K090892 — GE DATEX-OHMEDA S/5 ADU CARESTATION
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
Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems. Reusable CO2 absorbent canisters accessories may not seal properly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.