Recall Z-0020-2009 ยท BSZ Gas-Machine, Anesthesia
Datex - Ohmeda, Inc
GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as GE Healthcare, GE Healthcare PO Box 7550, Madison, WI. 53707-7550 Datex-Ohmeda Aisys Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environ
| Date | Oct 6, 2008 (initiated Aug 28, 2008) |
| Status | Terminated |
| Reason | The electronic vaporization system in the GE Aisys Anesthesia machine contains the following components: Backpressure Valve, Inflow Check Valve and Cassette Interface Board, that can contribute to independent failures. |
| Root cause | Manufacturing material removal |
| Action | GE Healthcare "Urgent Medical Device Correction" letters dated 8/12/08 were sent on 8/20/08 individually to Health Administrator/Risk Manger, Head of Anesthesia and Director of Clinical Engineering. The letters described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. The Safety Instructions state that the machines can be safely used as long as the following guidelines are followed: 1. Carry out the daily system checkout for any system in use. 2. The Aisys Anesthesia will alert the user both visually and audibly if it detects a fau |
| Quantity | 1571 |
| Distribution | Worldwide Distribution --- USA including states of AL, AK, CA, CO, FL, GA, IL, IN, KS, KY, ME , MD, MA, MI, MO, MT, NE, NV, NH, NY, NC, OH, OK, SC, SD, TX, VA, WV, WI, and DC, and countries of SOUTH AFRICA, TURKEY, THAILAND, SINGAPORE, SWEDEN, SAUDI ARABIA, QATAR, PORTUGAL POLAND, NEW ZEALAND, NORWA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073707 | GE DATEX-OHMEDA AISYS Datex-Ohmeda, Inc., Jan 30, 2008 |