GE Healthcare, LLC: Medical Device Recall in 2013 - (Recall #: Z-1443-2013)
See the recall detail below. You can also see other recalls from the same firm in 2013.
Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support.
Class II
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.
Canisters with date code of 02-2013 (Feb 2013)
Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, CT, ID, MK, MI, NJ, NY, OH, TN, TX, and VA, and the countries of INDIA, AUSTRALIA, BAHRAIN, BANGLADESH, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDONESIA, IRAQ,ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA,LEBANON, MALAYSIA, MEXICO, NETHERLAND,NEW ZEALAND, OMAN, PARAGUAY, PERU., PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, THAILAND, TURKEY, UNITED ARAB EMIRATES , UNITED KINGDOM, and VIET NAM.
Voluntary: Firm initiated