GE Ventilator and Anesthesia Machines Get Class I Recall Status from FDA

GE Healthcare's Engström Ventilator faces a Class I recall over an issue that could lead to patient injury or death. In addition to the ventilator, the company's Aespire View, Aisys, Avance, and Avance CS2 Anesthesia Machines are impacted by the issue.

Under normal operating conditions, the Engström Ventilator and the anesthesia machines listed above provide ventilation support and general inhalation anesthesia for neonatal, pediatric and adult patients. The devices can provide pressure or volume control ventilation.

The buttons on the display of the above systems could be unresponsive as a result of a manufacturing defect. In particular, some buttons on the bottom, left and right keypads may not reliably detect button presses. This could cause a delay when entering certain menu options on the impacted devices, potentially leading to a critical delay in treatment.

Impacted devices were manufactured from April 23 through July 22 of 2013. In its recall, GE Healthcare notes that the device will usually respond if a button is pressed twice. In addition, the company states that the control wheel can provide an alternative means to access device menus. If the above remedies don't work, the company advises impacted customers to contact a GE Healthcare service representative as soon as possible.

All affected devices will be repaired or replaced at no cost to the customer.

For more on recent Class I recalls, see This Month in Recalls: October 2013.