GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilatio

FDA device recall Z-0010-2014 · posted 2013-10-15 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstrm ventilator and the Aespire View, Aisys, and Avance anesthesia machines. As a result of a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect button presses. This may result in the inability to access certain menu functions wh

Action taken

Consignees were sent on 8/28/2013 a GE Healthcare "Urgent Medical device Correction" letter dated August 28, 2013. 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, Safety Instructions, Affected Product Details, Product Correction and Contact Information (1-800-345-2700 US).

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

BSZ

Quantity affected

911 (252 US, 659 OUS)

Distribution

Worldwide Distribution-USA (nationwide) including the states of US: AK, AZ, CA, CO, DE, FL, GA, IL, KY, LA, MD, MI, MN, MS, MT, NV, NY, NC, OH, OR, PA, SC, TX, WY, and WI and the countries of AUSTRALI

Date initiated

2013-08-28

Date posted

2013-10-15

Date terminated

2015-01-30

Location

Waukesha, WI

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