Recall Z-1787-2012 ยท CBK Ventilator, Continuous, Facility Use
GE Healthcare, LLC
GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
| Date | Jun 17, 2012 (initiated Apr 10, 2012) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Potential for two (2) vaporizers delivering agent at the same time. This could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. This m |
| Root cause | Process control |
| Action | GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 10, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact GE Healthcare Customer or Technical Support at 800-345-2700 for questions regarding this notification. |
| Quantity | 8 |
| Distribution | Nationwide Distribution - including the states of AL, FL, GA, MO, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023366 | DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS Datex-Ohmeda, Inc., Oct 7, 2003 |