GE 麻醉機: Recall

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GE Healthcare Aisys and Avance Anesthesia Systems: Recall

Audience: Anesthesiology healthcare professionals[Posted 05/13/2010]

GE and FDA notified healthcare professionals of a Class I Recall of specific lots of the Aisys and Avance Anesthesia Systems. The control board wiring harnesses have a defect which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.

Healthcare professionals are encouraged to report adverse events related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Online: www.fda.gov/MedWatch/report.htm1
Phone: 1-800-332-1088
Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch [url=/Safety/MedWatch/HowToReport/DownloadForms/default.htm]Download Forms[/url]2 page, to address on the pre-addressed form
Fax: 1-800-FDA-0178
[05/12/2010 - [url=/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm211877.htm]Recall Notice[/url]3 - FDA]

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm211918.htm