Devices

Device Recall Aestiva MRI

Model / Serial
AMTU01048 AMTU01023 AMTU00163 AMTU01050 AMTU00172 AMTU00175 AMTU00176 AMTU01034 AMTU01047 AMTU01055 AMTU01001 AMTU01002 AMTU01021 AMTU01044 AMTU01042 AMTU01015 AMTU00178 AMTU00179 AMTU00162 AMTU01000 AMTU01012 AMTU01041 AMTU00167 AMTU01019 AMTU00177 AMTU01049 AMTU00171 AMTU00164 AMTU01066 AMTU01006 AMTU00168 AMTU01061 AMTU01060 AMTU01056 AMTU01057 AMTU01073 AMTU00154 AMTU00166 AMTU00174 AMTU01005 AMTU01035 AMTU00150 AMTU01024 AMTU01025 AMTU01026 AMTU01027 AMTU01037 AMTU00152 AMTU01040 AMTU01022 AMTU00157 AMTU00158 AMTU00159 AMTU00160 AMTU00170 AMTU01018 AMTU01009 AMTU01032 AMTU01046 AMTU01045 AMTU01020 AMTU01008 AMTU00165 AMTU01013 AMTU01014 AMTU01033 AMTU01016 AMTU01036 AMTU01038 AMTU00151 AMTU00169 AMTU01003 AMTU00161 AMTU01010 AMTU01064 AMTU01011 AMTU01004 AMTU01017 AMTU01031 AMTU01053 AMTU01058 AMTU01059 AMTU01039 AMTU01007
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide including PR except NH, VT, & WY. Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.
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.
Manufacturer
GE Medical Systems, LLC
1 Event
- Recall of Device Recall Aestiva MRI

Manufacturer

GE Medical Systems, LLC

Manufacturer Address
GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
Manufacturer Parent Company (2017)
General Electric Company
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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