Medical Devices

GE Healthcare – Engström Ventilator and Aespire View, Aisys, Avance, and Avance CS2 Anesthesia Machines

Recall Class: Class I

Date Recall Initiated: Aug. 28, 2013

Products: – Engström Ventilator and Aespire View, Aisys, Avance, and Avance CS2 Anesthesia Machines

To locate serial numbers of the affected products, refer to FDA’s Class I Recall information.

These products were manufactured from April 23, 2013 through July 22, 2013.

Use: The Engström Ventilator and Aespire View, Aisys, Avance, and Avance CS2 Anesthesia Machines are intended to provide general inhalation anesthesia and ventilator support to a wide-range of patients (neonatal, pediatric, and adult). These devices are intended for volume or pressure control ventilation.

Recalling Firm:
GE Healthcare
3000 N Grandview Blvd.
Waukesha, Wisconsin 53188-1615

Reason for Recall: There is a potential safety issue involving unresponsive buttons on the display of the Engström ventilator and Aespire View, Aisys, and Avance anesthesia machines. Due to a manufacturing issue the buttons on the left, right, and bottom keypads may not always detect a user’s button presses. This may result in the inability to access certain menu functions which could possibly lead to a delay in treatment and may cause serious adverse health consequences, including death.

Clinicians may continue using these devices but be aware of the potential safety issue. See instructions below under FDA Comments.

Public Contact: For additional information about this recall, customers may contact GE Healthcare’s Customer Service line (24 hours a day, 7 days a week) at 1-800-345-2700.

FDA District: Minneapolis District Office

FDA Comments:
On August 28, 2013 GE Healthcare began notifying customers with the affected devices through an “Urgent Medical Device Correction” letter. The letter described the safety issue, safety instructions, affected product details, product correction, and contact information.

Customers with the affected devices received the following instructions:

  1. The user may notice that a button press may not result in the desired function. Usually by pressing the key again, the device will respond as expected.
  2. If a button has no response, the menu function may be accessible through the use of the control wheel.

If none of the above steps can be performed, discontinue use and contact a GE Healthcare Service Representative.

GE Healthcare is following up with all customers and will correct all affected systems at no cost to customers

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
 

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Page Last Updated: 10/22/2013
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