Aisys Anesthesia System. Sold under the following recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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); ANAM00449, Not Applicable (1011-9000-000); ANAM01089, Not Applicable (1011-9000-000); 5453450-1, Not Applicable (2097674-001); 5453450-2, Not Applicable (2097674-001); 5453450-3, Not Applicable (2097674-001); 5453450-4, Not Applicable (2097674-001); 5453450-5, Not Applicable (2097674-001); 5453450-6, Not Applicable (2097674-001); 5453450-7, Not Applicable (2097674-001); 5453450-8, Not Applicable (2097674-001); 5480532-1, Not Applicable (2097674-001); 5447751-1, Not Applicable (2097674-001); 5447751-10, Not Applicable (2097674-001); 5447751-11, Not Applicable (2097674-001); 5447751-12, Not Applicable (2097674-001); 5447751-13, Not Applicable (2097674-001); 5447751-14, Not Applicable (2097674-001); 5447751-15, Not Applicable (2097674-001); 5447751-16, Not Applicable (2097674-001); 5447751-17, Not Applicable (2097674-001); 5447751-18, Not Applicable (2097674-001); 5447751-19, Not Applicable (2097674-001); 5447751-2, Not Applicable (2097674-001); 5447751-20, Not Applicable (2097674-001); 5447751-21, Not Applicable (2097674-001); 5447751-22, Not Applicable (2097674-001); 5447751-23, Not Applicable (2097674-001); 5447751-24, Not Applicable (2097674-001); 5447751-3, Not Applicable (2097674-001); 5447751-4, Not Applicable (2097674-001); 5447751-5, Not Applicable (2097674-001); 5447751-6, Not Applicable (2097674-001); 5447751-7, Not Applicable (2097674-001); 5447751-8, Not Applicable (2097674-001); 5447751-9, Not Applicable (2097674-001); 5452649-1, Not Applicable (2097674-001); 5452649-2, Not Applicable (2097674-001); 5474323-1, Not Applicable (2097674-DE); ANAR05021, Not Applicable (1011-9000-000); 5473625-5, Not Applicable (2097674-NL); 5473625-6, Not Applicable (2097674-NL); 5473625-7, Not Applicable (2097674-NL); ANAK00330, Not Applicable (1011-9000-000); ANAK00332, Not Applicable (1011-9000-000); ANAK00334, Not Applicable (1011-9000-000); ANAL00806, Not Applicable (1011-9000-000); ANAL00807, Not Applicable (1011-9000-000); ANAL00808, Not Applicable (1011-9000-000); ANAL00809, Not Applicable (1011-9000-000); ANAN01010, Not Applicable (1011-9000-000); ANAN01011, Not Applicable (1011-9000-000); ANAN01012, Not Applicable (1011-9000-000); ANAN01013, Not Applicable (1011-9000-000); ANAN01014, Not Applicable (1011-9000-000); ANAP00399, Not Applicable (1011-9000-000); ANAP01133, Not Applicable (1011-9000-000); ANAR00344, Not Applicable (1011-9000-000); ANAR00896, Not Applicable (1011-9000-000); ANAR05978, Not Applicable (1011-9000-000); ANAR05979, Not Applicable (1011-9000-000); ANAR05980, Not Applicable (1011-9000-000); ANAR05981, Not Applicable (1011-9000-000); ANAR05982, Not Applicable (1011-9000-000); ANAR05983, Not Applicable (1011-9000-000); ANAR05984, Not Applicable (1011-9000-000); ANAS00709, Not Applicable (1011-9000-000); ANAS00710, Not Applicable (1011-9000-000); ANAS00711, Not Applicable (1011-9000-000); 5472401-2, Not Applicable (2097674-001); ANAP00132, Not Applicable (1011-9000-000); 5472557-4, Not Applicable (2097674-001); 5472557-5, Not Applicable (2097674-001); 5472557-6, Not Applicable (2097674-001); ANAN01045, Not Applicable (1011-9000-000); ANAN01046, Not Applicable (1011-9000-000); ANAR00327, Not Applicable (1011-9000-000); ANAS00345, Not Applicable (1011-9000-000); 5454764-3, Not Applicable (2097674-001); ANAP00584, Not Applicable (1011-9000-000); ANAP00585, Not Applicable (1011-9000-000); ANAP00586, Not Applicable (1011-9000-000); ANAP00587, Not Applicable (1011-9000-000); ANAP00588, Not Applicable (1011-9000-000); ANAP00589, Not Applicable (1011-9000-000); ANAP00825, Not Applicable (1011-9000-000); ANAP01215, Not Applicable (1011-9000-000); ANAS00738, Not Applicable (1011-9000-000); ANAL01390, Not Applicable (1011-9000-000); ANAL01391, Not Applicable (1011-9000-000); ANAS00391, Not Applicable (1011-9000-000); ANAR00492, Not Applicable (1011-9000-000); ANAR00493, Not Applicable (1011-9000-000); ANAR00494, Not Applicable (1011-9000-000); ANAR00495, Not Applicable (1011-9000-000); ANAR00496, Not Applicable (1011-9000-000); ANAR00497, Not Applicable (1011-9000-000); ANAR00498, Not Applicable (1011-9000-000); ANAR00499, Not Applicable (1011-9000-000); ANAR00500, Not Applicable (1011-9000-000); ANAR00501, Not Applicable (1011-9000-000); ANAR00756, Not Applicable (1011-9000-000); ANAR00757, Not Applicable (1011-9000-000); ANAL00705, Not Applicable (1011-9000-000); ANAL01040, Not Applicable (1011-9000-000); ANAL01041, Not Applicable (1011-9000-000); ANAL01042, Not Applicable (1011-9000-000); ANAL01043, Not Applicable (1011-9000-000); ANAL01044, Not Applicable (1011-9000-000); ANAL01045, Not Applicable (1011-9000-000); ANAL01046, Not Applicable (1011-9000-000); ANAL01047, Not Applicable (1011-9000-000); ANAL01048, Not Applicable (1011-9000-000); ANAL01050, Not Applicable (1011-9000-000); ANAM00335, Not Applicable (1011-9000-000); ANAL00192, Not Applicable (1011-9000-000); ANAL00754, Not Applicable (1011-9000-000); ANAL00755, Not Applicable (1011-9000-000); ANAL00756, Not Applicable (1011-9000-000); ANAL00757, Not Applicable (1011-9000-000); ANAL00764, Not Applicable (1011-9000-000); ANAL00769, Not Applicable (1011-9000-000); ANAL00776, Not Applicable (1011-9000-000); ANAL00777, Not Applicable (1011-9000-000); ANAL00778, Not Applicable (1011-9000-000); ANAL00779, Not Applicable (1011-9000-000); ANAL00780, Not Applicable (1011-9000-000); ANAL00781, Not Applicable (1011-9000-000); ANAL00782, Not Applicable (1011-9000-000); ANAL00783, Not Applicable (1011-9000-000); ANAL00784, Not Applicable (1011-9000-000); ANAL00785, Not Applicable (1011-9000-000); ANAL00786, Not Applicable (1011-9000-000); ANAL00787, Not Applicable (1011-9000-000); ANAL00788, Not Applicable (1011-9000-000); ANAL00789, Not Applicable (1011-9000-000); ANAL00790, Not Applicable (1011-9000-000); ANAL00791, Not Applicable (1011-9000-000); ANAL00792, Not Applicable (1011-9000-000); ANAL01541, Not Applicable (1011-9000-000); ANAL01542, Not Applicable (1011-9000-000); ANAP00810, Not Applicable (1011-9000-000); ANAP00811, Not Applicable (1011-9000-000); ANAS00938, Not Applicable (1011-9000-000); ANAP01070, Not Applicable (1011-9000-000); 5473409-1, Not Applicable (2097674-FR); 5473409-2, Not Applicable (2097674-FR); 5473409-3, Not Applicable (2097674-FR); ANAP00517, Not Applicable (1011-9000-000); ANAP00518, Not Applicable (1011-9000-000); ANAP00519, Not Applicable (1011-9000-000); ANAM01291, Not Applicable (1011-9000-000); ANAM01292, Not Applicable (1011-9000-000); ANAM01293, Not Applicable (1011-9000-000); ANAN00430, Not Applicable (1011-9000-000); ANAN00431, Not Applicable (1011-9000-000); ANAN00432, Not Applicable (1011-9000-000); ANAN00436, Not Applicable (1011-9000-000); ANAN00437, Not Applicable (1011-9000-000); ANAP00300, Not Applicable (1011-9000-000); ANAQ00766, Not Applicable (1011-9000-000); ANAS00753, Not Applicable (1011-9000-000); ANAP00492, Not Applicable (1011-9000-000); ANAP00493, Not Applicable (1011-9000-000); ANAM00628, Not Applicable (1011-9000-000); ANAL01029, Not Applicable (1011-9000-000); 5479515-1, Not Applicable (2097674-JA); 5479515-2, Not Applicable (2097674-JA); 5479515-3, Not Applicable (2097674-JA); 5479515-4, Not Applicable (2097674-JA); 5479515-5, Not Applicable (2097674-JA); 5479515-6, Not Applicable (2097674-JA); 5479515-7, Not Applicable (2097674-JA); 5479515-8, Not Applicable (2097674-JA); 5479515-9, Not Applicable (2097674-JA); 5480673-1, Not Applicable (2097674-JA); 5480673-2, Not Applicable (2097674-JA); 5480673-3, Not Applicable (2097674-JA); 5480673-4, Not Applicable (2097674-JA); 5480673-5, Not Applicable (2097674-JA); 5480673-6, Not Applicable (2097674-JA); 5480673-7, Not Applicable (2097674-JA); 5480673-8, Not Applicable (2097674-JA); 5483069-1, Not Applicable (2097674-JA); ANAQ01435, Not Applicable (1011-9000-000); ANAM01312, Not Applicable (1011-9000-000); ANAM01313, Not Applicable (1011-9000-000); ANAM01315, Not Applicable (1011-9000-000); ANAM01317, Not Applicable (1011-9000-000); ANAM01318, Not Applicable (1011-9000-000); ANAM01320, Not Applicable (1011-9000-000); ANAM01324, Not Applicable (1011-9000-000); ANAM01325, Not Applicable (1011-9000-000); ANAL01313, Not Applicable (1011-9000-000); ANAL01314, Not Applicable (1011-9000-000); ANAL01315, Not Applicable (1011-9000-000); ANAL01316, Not Applicable (1011-9000-000); ANAL01317, Not Applicable (1011-9000-000); ANAL01318, Not Applicable (1011-9000-000); ANAL01319, Not Applicable (1011-9000-000); ANAL01320, Not Applicable (1011-9000-000); ANAM01302, Not Applicable (1011-9000-000); ANAM01304, Not Applicable (1011-9000-000); ANAN00487, Not Applicable (1011-9000-000); ANAN00488, Not Applicable (1011-9000-000); ANAN00489, Not Applicable (1011-9000-000); ANAN00490, Not Applicable (1011-9000-000); ANAN00491, Not Applicable (1011-9000-000); ANAN00492, Not Applicable (1011-9000-000); ANAR05143, Not Applicable (1011-9000-000); ANAR05144, Not Applicable (1011-9000-000); 5450447-2, Not Applicable (2097674-NL); 5450447-4, Not Applicable (2097674-NL); 5454351-1, Not Applicable (2097674-NL); 5454351-2, Not Applicable (2097674-NL); ANAR00198, Not Applicable (1011-9000-000); ANAR00199, Not Applicable (1011-9000-000); ANAR00200, Not Applicable (1011-9000-000); ANAR00279, Not Applicable (1011-9000-000); ANAM01311, Not Applicable (1011-9000-000); ANAM01314, Not Applicable (1011-9000-000); ANAM01316, Not Applicable (1011-9000-000); ANAM01319, Not Applicable (1011-9000-000); ANAM01321, Not Applicable (1011-9000-000); ANAM01322, Not Applicable (1011-9000-000); ANAM01323, Not Applicable (1011-9000-000); 5456012-1, Not Applicable (2097674-001); 5456012-2, Not Applicable (2097674-001); 5456012-3, Not Applicable (2097674-001); 5456719-1, Not Applicable (2097674-001); ANAN01065, Not Applicable (1011-9000-000); ANAN01066, Not Applicable (1011-9000-000); 5476468-1, Not Applicable (2097674-001); 5476468-10, Not Applicable (2097674-001); 5476468-11, Not Applicable (2097674-001); 5476468-12, Not Applicable (2097674-001); 5476468-13, Not Applicable (2097674-001); 5476468-14, Not Applicable (2097674-001); 5476468-15, Not Applicable (2097674-001); 5476468-16, Not Applicable (2097674-001); 5476468-17, Not Applicable (2097674-001); 5476468-2, Not Applicable (2097674-001); 5476468-3, Not Applicable (2097674-001); 5476468-4, Not Applicable (2097674-001); 5476468-5, Not Applicable (2097674-001); 5476468-6, Not Applicable (2097674-001); 5476468-7, Not Applicable (2097674-001); 5476468-8, Not Applicable (2097674-001); 5476468-9, Not Applicable (2097674-001); Additional Serial Numbers - Model Number, UDI Number, (Serial Number): 2097674-001-US, Not Applicable, (APWV01271); 2097674-001-US, Not Applicable, (APWU01812); 2097674-001-US, Not Applicable, (ANAR00714); 2097674-001-US, Not Applicable, (ANAR00741); 2097674-001-US, Not Applicable, (ANAS00330); 2097674-001-US, Not Applicable, (ANAS01319); 2097674-001-US, Not Applicable, (ANAS01320); 2097674-001-US, Not Applicable, (APWU00486); 2097674-001-US, Not Applicable, (APWU00487); 2097674-001-US, Not Applicable, (APWU00575); 2097674-001-US, Not Applicable, (APWU01267); 2097674-001-US, Not Applicable, (APWX00154); 2097674-001-US, Not Applicable, (APWX00155); 2097674-001-US, Not Applicable, (APWX00156); 2097674-001-US, Not Applicable, (APWX00157); 1011-9000-000, Not Applicable, (ANAS00456); 2097674-001-US, Not Applicable, (ANAM00764); 2097674-001-US, Not Applicable, (ANAM00765); 2097674-001-US, Not Applicable, (ANAM00766); 2097674-001-US, Not Applicable, (ANAM00767); 2097674-001-US, Not Applicable, (ANAM00768); 2097674-001-US, Not Applicable, (ANAM00769); 2097674-001-US, Not Applicable, (ANAM00770); 2097674-001-US, Not Applicable, (ANAM00771); 2097674-001-US, Not Applicable, (ANAM00772); 2097674-001-US, Not Applicable, (ANAM00773); 2097674-001-US, Not Applicable, (ANAM00774); 2097674-001-US, Not Applicable, (ANAM00775); 2097674-001-US, Not Applicable, (APWV00946); 2097674-001, Not Applicable, (ANAL00264); 2097674-001, Not Applicable, (ANAL00265); 2097674-001, Not Applicable, (ANAL00266); 2097674-001, Not Applicable, (ANAK00415); 2097674-001, Not Applicable, (ANAK00703); 2097674-001, Not Applicable, (ANAK00705); 2097674-001, Not Applicable, (ANAK00707); 2097674-001, Not Applicable, (ANAK00709); 2097674-001, Not Applicable, (ANAK00410); 2097674-001, Not Applicable, (ANAK00411); 2097674-001, Not Applicable, (ANAK00413); 2097674-001, Not Applicable, (ANAK00414); 2097674-001, Not Applicable, (ANAK00416); 2097674-001, Not Applicable, (ANAK00417); 2097674-001, Not Applicable, (ANAK00421); 2097674-001, Not Applicable, (ANAL00893); 2097674-001, Not Applicable, (APWU02246); 2097674-001, Not Applicable, (APWV00404); 2097674-001, Not Applicable, (ANAK00412); 2097674-001, Not Applicable, (ANAK00418); 2097674-001, Not Applicable, (ANAK00419); 2097674-001, Not Applicable, (ANAK00420); 2097674-001, Not Applicable, (ANAK00704); 2097674-001, Not Applicable, (ANAK00706); 2097674-001, Not Applicable, (ANAK00708); 2097674-001, Not Applicable, (APWW00334); 1011-9000-000, Not Applicable, (ANAR05371); 2097674-DE, Not Applicable, (ANAS00870); 1011-9000-000, Not Applicable, (ANAR00333); 1011-9000-000, Not Applicable, (ANAJ00122); 1011-9000-000, Not Applicable, (ANAQ01270); 1011-9000-000, Not Applicable, (ANAQ01271); 1011-9000-000, Not Applicable, (ANAQ01272); 1011-9000-000, Not Applicable, (ANAQ01273); 1011-9000-000, Not Applicable, (ANAQ01274); 1011-9000-000, Not Applicable, (ANAQ01275); 1011-9000-000, Not Applicable, (ANAQ01276); 1011-9000-000, Not Applicable, (ANAQ01277); 1011-9000-000, Not Applicable, (ANAR00187); 1011-9000-000, Not Applicable, (ANAR00188); 1011-9000-000, Not Applicable, (ANAR00189); 1011-9000-000, Not Applicable, (ANAR00190); 1011-9000-000, Not Applicable, (ANAR00191); 1011-9000-000, Not Applicable, (ANAR00192); 1011-9000-000, Not Applicable, (ANAR00334); 1011-9000-000, Not Applicable, (ANAR00701); 1011-9000-000, Not Applicable, (APWU02039); 1011-9000-000, Not Applicable, (APWW01068); 2097674-001, Not Applicable, (ANAQ00825); 1011-9000-000, Not Applicable, (ANAR05370); 2097674-FR, Not Applicable, (ANAN01100); 1011-9000-000, Not Applicable, (ANAT00157); 1011-9000-000, Not Applicable, (ANAT00158); 1011-9000-000, Not Applicable, (ANAT00156); 1011-9000-000, Not Applicable, (ANAR05372);

Product

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…

Recalling firm

GE Healthcare, LLC

Quantity

4,207 units total

Distribution

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.

Recall date

November 21, 2018

Classification

Class II

Status

Terminated

Agency

FDA (device)