FDAFDA · Food and drugs·Recall number Z-0411-2019

Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE.

Published November 21, 2018 · Recall initiated: September 27, 2018

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: GE Healthcare, LLC
Distributor: Worldwide distribution - US nationwide in the states of CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, ,MA, MD, MI, MN, MO, MT, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Countries of Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea (Republic of), Kuwait, Macedonia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.
Lot: Model Number, UDI Number, (Serial Number): 2097674-001-US, Not Applicable, (5470345-30); 2097674-001-US, Not Applicable, (5470345-31); 2097674-001-US, Not Applicable, (5470345-32); 1011-9000-000, Not Applicable, (ANAK00774); 1011-9000-000, Not Applicable, (ANAK00775); 1011-9000-000, Not Applicable, (ANAL01201); 1011-9000-000, Not Applicable, (ANAL01234); 1011-9000-000, Not Applicable, (ANAL01235); 1011-9000-000, Not Applicable, (ANAL01236); 1011-9000-000, Not Applicable, (ANAL01237); 1011-9000-000, Not Applicable, (ANAL01238); 1011-9000-000, Not Applicable, (ANAL01240); 1011-9000-000, Not Applicable, (ANAL01494); 1011-9000-000, Not Applicable, (ANAL01495); 1011-9000-000, Not Applicable, (ANAL01551); 1011-9000-000, Not Applicable, (ANAM01023); 1011-9000-000, Not Applicable, (ANAM01024); 1011-9000-000, Not Applicable, (ANAM01025); 1011-9000-000, Not Applicable, (ANAM01026); 1011-9000-000, Not Applicable, (ANAM01027); 1011-9000-000, Not Applicable, (ANAM01104); 1011-9000-000, Not Applicable, (ANAM01105); 1011-9000-000, Not Applicable, (ANAP00438); 1011-9000-000, Not Applicable, (ANAP00439); 1011-9000-000, Not Applicable, (ANAQ01188); 1011-9000-000, Not Applicable, (ANAR05264); 1011-9000-000, Not Applicable, (ANAR05265); 1011-9000-000, Not Applicable, (ANAR05610); 1011-9000-000, Not Applicable, (ANAR05611); 1011-9000-000, Not Applicable, (ANAS00202); 1011-9000-000, Not Applicable, (ANAS00203); 1011-9000-000, Not Applicable, (ANAS00204); 2097674-001-US, Not Applicable, (5479630-1); ANAK00798, Not Applicable (1011-9000-000); ANAK00799, Not Applicable (1011-9000-000); ANAK00803, Not Applicable (1011-9000-000); ANAK00807, Not Applicable (1011-9000-000); ANAK00814, Not Applicable (1011-9000-000); ANAK00839, Not Applicable (1011-9000-000); ANAK00864, Not Applicable (1011-9000-000); 5481223-1, Not Applicable (2097674-001-US); 5481223-10, Not Applicable (2097674-001-US); 5481223-11, Not Applicable (2097674-001-US); 5481223-12, Not Applicable (2097674-001-US); 5481223-2, Not Applicable (2097674-001-US); 5481223-3, Not Applicable (2097674-001-US); 5481223-4, Not Applicable (2097674-001-US); 5481223-5, Not Applicable (2097674-001-US); 5481223-6, Not Applicable (2097674-001-US); 5481223-7, Not Applicable (2097674-001-US); 5481223-8, Not Applicable (2097674-001-US); 5481223-9, Not Applicable (2097674-001-US); ANAP00712, Not Applicable (1011-9000-000); ANAP00713, Not Applicable (1011-9000-000); ANAP00714, Not Applicable (1011-9000-000); ANAN01125, Not Applicable (1011-9000-000); ANAN01138, Not Applicable (1011-9000-000); 4652664-1, Not Applicable (2097674-001-US); 4652664-10, Not Applicable (2097674-001-US); 4652664-11, Not Applicable (2097674-001-US); 4652664-12, Not Applicable (2097674-001-US); 4652664-13, Not Applicable (2097674-001-US); 4652664-2, Not Applicable (2097674-001-US); 4652664-3, Not Applicable (2097674-001-US); 4652664-4, Not Applicable (2097674-001-US); 4652664-5, Not Applicable (2097674-001-US); 4652664-6, Not Applicable (2097674-001-US); 4652664-7, Not Applicable (2097674-001-US); 4652664-8, Not Applicable (2097674-001-US); 4652664-9, Not Applicable (2097674-001-US); ANAK00156, Not Applicable (1011-9000-000); ANAK00157, Not Applicable (1011-9000-000); ANAK00158, Not Applicable (1011-9000-000); ANAK00159, Not Applicable (1011-9000-000); ANAK00511, Not Applicable (1011-9000-000); ANAK00512, Not Applicable (1011-9000-000); ANAK00513, Not Applicable (1011-9000-000); ANAK00514, Not Applicable (1011-9000-000); ANAN01051, Not Applicable (1011-9000-000); ANAN01052, Not Applicable (1011-9000-000); ANAP00545, Not Applicable (1011-9000-000); ANAP00546, Not Applicable (1011-9000-000); ANAP00708, Not Applicable (1011-9000-000); ANAL01400, Not Applicable (1011-9000-000); ANAL01401, Not Applicable (1011-9000-000
Risk classification: Class II
Area (FDA): device
Country: United States

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