Recall Z-1196-06 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare
Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The Anesthesia Delivery Unit is designed to mix and dose respiratory gases and to ventilate the patient. The delivery unit is the basis for a flexible anesthesia system with full monitoring and data management capabilities.
| Date | Jul 12, 2006 (initiated Mar 22, 2006) |
| Status | Terminated |
| Reason | There exists the possibility that the ADU Fresh Gas Control unit (A-FGC1) can shut off during normal handling of the anesthesia machine and result in no anesthetic agent output. |
| Root cause | Other |
| Action | An Urgent Medical Device Correction letter dated March 21, 2006, was sent to customers. It warns of the potential for no anesthetic agent output. The letter contains short term recommendations for use of the device until a GE Healthcare representative contacts the facility to schedule a vist and implelment corrective action. |
| Quantity | 62 |
| Distribution | World wide-(including the States of IA, CA, MI, FL, MI, TX, IL, WI, OH, and countries of Finland, Singapore, Austria, South Africa, Sweden, Israel, Norway, Taiwan, Germany, Turkey, Portugal, Italy, Switzerland, Great Britain, and France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973985 | AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) Datex-Engstrom, Inc., Oct 30, 1998 |