Recall Z-1443-2013 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare, LLC
Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support.
| Date | Jun 3, 2013 (initiated May 14, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Component change control |
| Action | GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter April 30, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Fax back form was included with the letter requesting the consignees to complete and return. |
| Quantity | 800 |
| Distribution | 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, FRA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090892 | GE DATEX-OHMEDA S/5 ADU CARESTATION GE Healthcare Finland Oy, Apr 30, 2009 |
| K110213 | GE DATEX-OHMEDA AISYS Datex-Ohmeda, Inc., Jul 20, 2011 |
| K112722 | GE DATEX-OHMEDA AVANCE Datex-Ohmeda, Inc., Dec 16, 2011 |
| K122445 | AESPIRE 7900, AESPIRE VIEW Datex-Ohmeda, Oct 12, 2012 |
| K123125 | GE DATEX-OHMEDA AVANCE CS2 Datex-Ohmeda, Inc., Feb 6, 2013 |