FDA-Device2016-05-04Class II
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).
GE Medical Systems, LLC
Hazard
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.
Sold states
Worldwide Distribution -- US, to the states of AZ, CA, DC, FL, GA, ID, IL IN, KY, MD, MI, MN, MO, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and, to the countries of AUSTRALIA, BELGIUM. BOLIVIA, CANADA, CHILE, DENMARK, FINLAND, FRANCE, GERMANY, HUNGARIA, INDIA, IRELAND, JAPAN, KAZAKHSTAN, KOREA, KUWAIT, NETHERLANDS, NEW ZEALAND, SAUDI ARABIA, SPAIN, SWITZERLAND, THAILAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Affected count
952 (488 US; 464 OUS)
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1562-2016Don't want to check this manually?
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