Recall Z-1381-2016— GE Medical Systems, LLC

Name: FDA recall Z-1381-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-17

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2016-02-17, terminated 2018-09-04. It names one FDA 510(k) clearance: K132530. Product: GE Healthcare, Aisys CS2 anesthesia... Reason: GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-02-17
Terminated: 2018-09-04
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

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

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 CS2 anesthesia..

Reason for recall

GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices.

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