GE Healthcare, LLC recalls Aisys Anesthesia System. Sold under the following product n

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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);