SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 014 10 18 000
Date submitted:	10/7/2018

Manufacturer:	Datex - Ohmeda Inc
Device Type:	Aisys and Aisys CS2 Anesthesia Devices
Description:	Anesthesia Units
Medical Device Identifier:	All upgraded Aisys anesthesia devices (i.e. Aisys devices upgraded to software version 11) and Aisys CS2 anesthesia devices (GTIN: 840682102292) with PSVPro option and/or End Tidal Control option. Software versions other than 11.00 and 11 SP01 are not affected.
Reason of Field Safety Corrective Action:	Safety Issue #1: Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices utilizing End-Tidal Control (EtC mode) on rare occasions may lose ability to change Fresh Gas and Agent settings when stopping the EtC mode. Safety Issue #2: Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode.
Remedy Action:	GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction.
Athorized Representative/Importer/Distributor:	GE Healthcare
Report Source:	NCMDR
Source Ref. Number:	F92CF3280A24A
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Datex - Ohmeda Inc.pdf

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