AESTIVA/5

Anesthesiology Devices

Medical Device Safety Alert: GE Healthcare, Aestiva/5 7900 SmartVent

Serial Number AMRP01031 AMRP00966 AMRP01030 AMRP00968 AMRP00967 AMRP01033 AMRP00970 AMRP00969

Anesthesiology Devices

2

No

Nationwide Distribution - including the states of AL, FL, GA, MO, and VA.

GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.

Serial numbers AMRG02807, AMRG02889 thru AMRG02899, AMRG02930, AMRG02937 thru AMRG02942, AMRG02955, AMRG02958, AMRG02967, AMRG02968, AMRG02969, AMRG02979 thru AMRG03005, AMRG03012 thru AMRG03014, AMRG03017, AMRG03018, AMRG03030, AMRG03057 thru AMRG03062, AMRG03072, AMRG03077, AMRG03080, AMRG03081, AMRG03084, thru AMRG03088, AMRG03115, AMRG03155, AMRG03156, AMRG03174, AMRG03180 thru AMRG03185, AMRG03198, AMRG03199, AMRG03201, AMRG03208, AMRG03209, AMRG03212 thru AMRG03215, AMRG03222 thru AMRG03224, AMRG03261 thru AMRG03270, AMRG03298 thru AMRG03306, AMRG03331 thru AMRG03347, AMRG03351 thru AMRG03353, AMRH00124, thru AMRH00140, AMRH00143, AMRH00151, AMRH00152, AMRH00163, AMRH00169, AMRH00169, AMRH00170, AMRH00174 thru AMRH00181, AMRH00184, AMRH00185, AMRH00190 thru AMRH00202, AMRH00232 thru AMRH00237, AMRH00243, AMRH00244, AMRH00246, AMRH00247, AMRH00259, thru AMRH00276, AMRH00290 thru AMRH00307, AMRH00309, thru AMRH00311, AMRH00328, AMRH00329, AMRH00363 thru AMRH00368, AMRH00376, AMRH00382, thru AMRH00387, AMRH00396 thru AMRH00399, AMRH00399, AMRH00429, AMRH00430, AMRH00433, thru AMRH00439, AMRH00445 thru AMRH00464, AMRH00468, AMRH00469, AMRH00472 thru AMRH00474, AMRH00497 thru AMRH00502, AMRH00511 thru AMRH00513, AMRH00538 AMRH00543, AMRH00561 thru AMRH00571 thru AMRH00587, AMRH00589 thru AMRH00591, AMRH00594, AMRH00597 thru AMRH00603, AMRH00605 thru AMRH00626, AMRH00628 thru AMRH00636, AMRH00651, AMRH00652, AMRH00655 thru AMRH00657, AMRH00659 thruAMRH00661, AMRH00663 thru AMRH00669, AMRH00671, AMRH00672, AMRH00674 thru AMRH00676, AMRH00682, AMRH00684, and AMRH00704 thru AMRH00717

Anesthesiology Devices

2

No

The affected units were distributed nationwide in the United States and worldwide.

Datex-Ohmeda Aestiva/5 Active Gas Scavenging System used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine

Serial numbers AMVG01045, AMVG01047, AMVG01052, AMVG01062, AMVG01072 thru AMVG01083, AMVH00100 thru AMVH00109, AMVH00116, AMVH00125, AMVH00126, AMVH00129, AMVH00132, AMVH00133, AMVH00139, AMVH00141 thru AMVH00148, AMVH00151 thru AMVH00154, AMVH00159, AMVH00160, AMVH00164, AMVH00166, AMVH00159, AMVH00160, AMVH00164, AMVH00166, AMVH00171 thru AMVH00186, AMVH00195 thru AMVH00198, AMVH00211, and AMVH00228 thru AMVH00230

Anesthesiology Devices

2

No

The affected units were distributed nationwide in the United States and worldwide.

Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5 Anesthesia Machine.

Serial numbers AMTG00208, AMTG00212, AMTG00213, AMTG00216, AMTG00219, AMTG00220, AMTG00222, AMTH00113, AMTH00121, and AMTH00124

Anesthesiology Devices

2

No

The affected units were distributed nationwide in the United States and worldwide.

Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, Part Number 1406-8216-000, used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine, in a Magnetic Reasonance Suite.