GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

FDA device recall Z-0009-2011 · posted 2010-10-06 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

Users may inadvertently leave a test plug in the inspiratory flow sensor after completing Low P Leak Check on the SCGO (Switched Common Gas Outlet) configuration of Avance, Amingo, and Aisys anesthesia machines that may impact patient safety. If the test plug remains in place and therapy is initiated, the machine will not provide gas to the patient. This would inhibit mechanical or manual ventila

Action taken

GE Healthcare issued an " Urgent Medical Device Correction" letter dated August 30, 2010 to consignees. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager and Director of Biomedical/ Clinical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Instructions. Customers were instructed to: 1. Ensure the plug is removed at the completion of the Low P Leak check. 2. Review the Preoperative Checkout procedure listed in section 4 of the User Reference Manual with appropriate personnel. Ensure that the Preoperative Checkout procedure is completed in its entirety prior to each case, or as required. All facilities will be contacted by their local GE GE Field Technical Service Team to schedule installation of a software update and a revised test plug for your machines configured with SCGO. Customers are to contact their local GE Healthcare Customer or Technical Support Representative if they need additional information.

Root cause

Employee error

Status

Terminated

Product code

BSZ

Quantity affected

4541

Distribution

Worldwide Distribution: USA: All States, including DC, except Delaware, and the countries of YEMEN, VIETNAM, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SYRIA, SWITZERLAND, SWED

Date initiated

2010-08-30

Date posted

2010-10-06

Date terminated

2012-09-13

Location

Waukesha, WI

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