Recall Z-0679-2016— GE Medical Systems, LLC

Name: FDA recall Z-0679-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-15

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2015-12-15, terminated 2016-09-21. It names one FDA 510(k) clearance: K050055. Product: GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The Aestiva/5 MRI anesthesia system provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment.. Reason: The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-12-15
Terminated: 2016-09-21
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K050055 — GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEMDatex-Ohmeda, Inc.·cleared 2005-02-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The Aestiva/5 MRI anesthesia system provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment.

Reason for recall

The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

Data sourced from openFDA. This site is unofficial and independent of the FDA.