GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
FDA device recall Z-1787-2012 · posted 2012-06-17 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 8
- Distribution
- Nationwide Distribution - including the states of AL, FL, GA, MO, and VA.
- Date initiated
- 2012-04-10
- Date posted
- 2012-06-17
- Date terminated
- 2012-07-09
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS (K023366) | Datex-Ohmeda, Inc. | 2003-10-07 |