FDA-Device2015-04-08Class II
GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients
GE Healthcare
Hazard
Specific Aespire 7900 Anesthesia Machines have an increased likelihood of failure of the CPU circuit board. This could result in a blank display or loss of mechanical ventilation.
Sold states
Worldwide Distribution -- US, including the states of NC and OK; and the countries of CHINA, INDIA, JAPAN, MEXICO, and VENEZUELA.
Affected count
46 (10 units US, 36 units OUS)
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1376-2015Don't want to check this manually?
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