The United States Food and Drug Administrations (FDA) has issued a Class I recall concerning Aestiva/5 7900 SmartVent (Serial number AMRP01031 AMRP00966 AMRP01030 AMRP00968 AMRP00967 AMRP01033 AMRP00970 AMRP00969), manufactured by GE Healthcare, LLC.
The manufacturer has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of the Aestiva 7900 Anesthesia Device. There is a potential for two 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 may cause prolonged or persistent hypotension requiring medical intervention. To date, no injury has been reported to GE Healthcare associated with this issue.
According to the local supplier, the affected products were not distributed in Hong Kong.
For details, please refer to FDA websites
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=61639&w=06272012
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 28 June 2012