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FDAFDA · Food and drugs·Recall number Z-2171-2024

CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-01023150, 4) 2095801-001-01023151, 5) 2095801-001-01023152, 6) 2095801-001-01032962, 7) 2095801-001-01033915, 8) 2095801-001-01034302, 9) 2095801-001-01034399, 10) 2095801-001-01034528, 11) 2095801-001-01034573, 12) 2095801-001-01035087, 13) 2095801-001-01036384, 14) 2095801-001-01037712, 15) 2095801-001-01038022, 16) 2095801-001-01038593, 17) 2095801-001-01041035, 18) 2095801-001-01041611, 19) 2095801-001-01041694, 20) 2095801-001-01042512, 21) 2095801-001-01043771, 22) 2095801-001-01043810, 23) 2095801-001-01043815, 24) 2095801-001-01044650, 25) 2095801-001-01045256, 26) 2095801-001-01045394, 27) 2095801-001-01047045, 28) 2095801-001-01047175, 29) 2095801-001-01047424, 30) 2095801-001-01047840, 31) 2095801-001-01048362, 32) 2095801-001-01048417, 33) 2095801-001-01048980, 34) 2095801-001-01051456, 35) 2095801-001-01052158, 36) 2095801-001-01052233, 37) 2095801-001-01055544, 38) 2095801-001-01056326, 39) 2095801-001-01057436, 40) 2095801-001-01059243, 41) 2095801-001-01059748, 42) 2095801-001-01063874, 43) 2095801-001-01065225, 44) 2095801-001-01066765, 45) 2095801-001-01068762, 46) 2095801-001-01068763, 47) 2095801-001-01068789, 48) 2095801-001-01069489, 49) 2095801-001-01069499, 50) 2095801-001-01069511, 51) 2095801-001-01069736, 52) 2095801-001-01071206, 53) 2095801-001-01071246, 54) 2095801-001-01071369, 55) 2095801-001-01071456, 56) 2095801-001-01071457, 57) 2095801-001-01073465, 58) 2095801-001-01073479, 59) 2095801-001-01073480, 60) 2095801-001-01073804, 61) 2095801-001-01073821, 62) 2095801-001-01073831, 63) 2095801-001-01073833, 64) 2095801-001-01073842, 65) 2095801-001-01075357, 66) 2095801-001-01075506, 67) 2095801-001-01075588, 68) 2095801-001-01075714, 69) 2095801-001-01075924, 70) 2095801-001-01077403, 71) 2095801-001-01077441, 72) 2095801-001-01077461, 73) 2095801-001-01079833, 74) 2095801-001-01079863, 75) 2095801-001-01083142, 76) 2095801-001-01083734, 77) 2095801-001-01085418, 78) 2095801-001-01085443, 79) 2095801-001-01086276, 80) 2095801-001-01086712, 81) 2095801-001-01086761, 82) 2095801-001-01086774, 83) 2095801-001-01086812, 84) 2095801-001-01087472, 85) 2095801-001-01087477, 86) 2095801-001-01087541, 87) 2095801-001-01090666, 88) 2095801-001-01090675, 89) 2095801-001-01091331, 90) 2095801-001-01091461, 91) 2095801-001-01093653, 92) 2095801-001-01094099, 93) 2095801-001-01094103, 94) 2095801-001-01094107, 95) 2095801-001-01094246, 96) 2095801-001-01095946, 97) 2095801-001-01097590, 98) 2095801-001-01099368, 99) 2095801-001-01101966, 100) 2095801-001-01101967, 101) 2095801-001-01103899, 102) 2095801-001-01103993, 103) 2095801-001-01105509, 104) 2095801-001-01106417, 105) 2095801-001-01108128, 106) 2095801-001-01109198, 107) 2095801-001-01111183, 108) 2095801-001-01111184, 109) 2095801-001-01111601, 110) 2095801-001-01112917, 111) 2095801-001-01113476, 112) 2095801-001-01114061, 113) 2095801-001-01115803, 114) 2095801-001-01116299, 115) 2095801-001-01117382, 116) 2095801-001-01117424, 117) 2095801-001-01119791, 118) 2095801-001-01119805, 119) 2095801-001-01120649, 120) 2095801-001-01120762, 121) 2095801-001-01123351, 122) 2095801-001-01124300, 123) 2095801-001-01126694, 124) 2095801-001-01127783, 125) 2095801-001-01128064, 126) 2095801-001-01128764, 127) 2095801-001-01130112, 128) 2095801-001-01132721, 129) 2095801-001-01133150, 130) 2095801-001-01133492, 131) 2095801-001-01133517, 132) 2095801-001-01134200, 133) 2095801-001-01135675, 134) 2095801-001-01135943, 135) 2095801-001-01137569, 136) 2095801-001-01138299, 137) 2095801-001-01140050, 138) 2095801-001-01141178, 139) 2095801-001-01149187, 140) 2095801-001-01152254, 141) 2095801-001-01153436, 142) 2095801-001-01155553, 143) 2095801-001-01156974, 144) 2095801-001-01158167, 145) 2095801-001-011632

Published July 3, 2024 · Recall initiated: April 5, 2024

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

What's the hazard

GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
GE Healthcare Finland Oy
Distributor
Worldwide distribution.
Lot
GTIN 00840682143806: a) MBB313: 1) 2095801-001, Serial Numbers: STF21330010HA, STF21330023HA, STF21400190HA, SNS20303110SA, SNS20363001SA, SNS20392015SA, SS620481053HA; 2) 2095801-001-01018416, Serial Numbers: STF22200047HA, STF22200048HA, STF22200061HA, STF22200062HA, STF22200065HA, STF22200066HA, STF22200067HA, STF22200068HA, STF22200069HA, STF22200070HA, STF22200071HA, STF22200072HA, STF22200073HA, STF22200074HA, STF22200075HA, STF22200079HA; 3) 2095801-001-01023150, Serial Numbers: STF22311034HA, STF22311035HA, STF22311036HA, STF22311037HA; 4) 2095801-001-01023151, Serial Numbers: STF22311021HA, STF22311022HA, STF22311023HA, STF22311024HA, STF22311025HA, STF22311026HA, STF22311027HA, STF22311028HA, STF22311030HA, STF22311039HA, STF22311040HA, STF22311041HA, STF22311042HA, STF22311043HA, STF22311044HA, STF22311045HA, STF22311046HA, STF22311047HA, STF22311048HA, STF22311049HA, STF22311050HA, STF22311051HA, STF22311052HA, STF22311053HA, STF22311054HA, STF22311055HA, STF22311056HA, STF22311057HA, STF22311058HA, STF22311059HA, STF22311060HA, STF22311061HA, STF22311062HA, STF22311063HA, STF22311066HA, STF22311067HA, STF22311068HA, STF22311069HA, STF22311070HA, STF22311073HA, STF22311074HA, STF22311075HA, STF22311076HA, STF22311077HA, STF22311078HA, STF22311079HA, STF22311080HA, STF22311081HA, STF22311082HA, STF22311083HA, STF22311084HA, STF22311085HA, STF22311086HA, STF22311087HA, STF22311088HA, STF22311089HA, STF22311090HA; 5) 2095801-001-01023152, Serial Numbers: STF22311072HA; 6) 2095801-001-01032962, Serial Numbers: STF22280028HA, STF22280030HA, STF22200081HA, STF22270041HA, STF22270042HA, STF22450110HA, STF22450137HA, STF22200076HA, STF22200083HA, STF22200077HA, STF22250053HA, STF22250054HA, STF22250055HA, STF22250056HA, STF22260003HA, STF22270079HA, STF22250057HA, STF22270076HA, STF22270078HA, STF22200078HA, STF22200080HA, STF22200082HA; 7) 2095801-001-01033915, Serial Numbers: STF22312001SA, STF22312002SA, STF22312003SA, STF22312004SA, STF22312005SA, STF22312006SA, STF22312007SA, STF22312008SA, STF22312009SA, STF22312010SA, STF22312011SA, STF22312012SA, STF22312013SA, STF22312014SA, STF22312015SA, STF22312016SA, STF22312017SA, STF22312018SA, STF22312019SA, STF22312020SA, STF22312021SA, STF22312022SA, STF22312023SA, STF22312024SA, STF22312025SA, STF22312026SA, STF22312027SA, STF22312028SA, STF22312029SA, STF22312030SA, STF22312032SA, STF22312033SA, STF22312034SA, STF22312035SA, STF22312036SA, STF22312037SA, STF22312040SA, STF22312042SA, STF22312043SA, STF22312044SA, STF22312045SA, STF22312047SA; 8) 2095801-001-01034302, Serial Numbers: STF22440044HA; 9) 2095801-001-01034399, Serial Numbers: STF22200031HA, STF22200032HA, STF22200033HA, STF22200034HA, STF22200035HA, STF22200036HA, STF22200037HA, STF22200038HA, STF22200039HA, STF22200040HA; 10) 2095801-001-01034528, Serial Numbers: STF22302058SA; 11) 2095801-001-01034573, Serial Numbers: STF23082005SA, STF23082016SA; 12) 2095801-001-01035087, Serial Numbers: STF22262081SA; 13) 2095801-001-01036384, Serial Numbers: STF22392161SA, STF22392162SA, STF22402003SA, STF22402004SA, STF22402005SA, STF22402006SA, STF22402008SA, STF22402009SA, STF22402010SA, STF22402011SA, STF22402012SA, STF22402013SA, STF22402014SA, STF22402015SA, STF22402016SA, STF22402017SA, STF22402018SA, STF22402019SA; 14) 2095801-001-01037712, Serial Numbers: SNS22292010SA; 15) 2095801-001-01038022, Serial Numbers: STF22262087SA; 16) 2095801-001-01038593, Serial Numbers: STF22510003HA, STF22510011HA, STF22510012HA, STF22510013HA, STF22510014HA, STF22510015HA, STF22510016HA, STF22510017HA, STF22510018HA, STF22510019HA, STF22510020HA, STF22250013HA, STF22250014HA, STF22250015HA, STF22270071HA, STF22270073HA, STF22300024HA, STF22300027HA; 17) 2095801-001-01041035, Serial Numbers: STF22452107SA, STF22452108SA, STF22452112SA, STF22452114SA, STF22452115SA, STF22452116SA, STF22462002SA, STF22462003SA, STF22462004SA; 18) 2095801-001-01041611, Serial Numbers: STF22322093S
Risk classification
Class II
Area (FDA)
device
Country
Finland

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