Recall Z-1562-2016— GE Medical Systems, LLC

Name: FDA recall Z-1562-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-15

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2016-03-15, terminated 2016-11-07. It names 2 FDA 510(k) clearances: K132530, K110213. Product: GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).. Reason: The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in inadequate suction performance to clear the airway and inadequate ventilation of the patient..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-03-15
Terminated: 2016-11-07
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K132530 — GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)Datex-Ohmeda, Inc.·cleared 2013-12-20
K110213 — GE DATEX-OHMEDA AISYSDatex-Ohmeda, Inc.·cleared 2011-07-20

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, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).

Reason for recall

The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in inadequate suction performance to clear the airway and inadequate ventilation of the patient.

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