Z-2170-2024 Class II Ongoing

Recalled by GE Healthcare Finland Oy — Helsinki

Recall Details

Product Type
Devices
Report Date
July 3, 2024
Initiation Date
April 5, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
547 units

Product Description

CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317, f) 5514418-01086007, g) 5514418-01086838, h) 5514418-01088182, i) 5514418-01108442, j) 5514418-01118673, k) 5514418-01120764, l) 5514418-01166521, m) 5514418-01180241, n) 5514418-01181177, o) 5514418-01183037, p) 5514418-01184556, q) 5514418-01184557, r) 5514418-01185805, s) 5514418-01186277, t) 5514418-01187473, u) 5514418-01188453, v) 5514418-01190677, w) 5514418-01192703, x) 5514418-01192705, y) 5514418-01203242, z) 5514418-01206279, aa) 5514418-01208248, bb) 5514418-01212670, cc) 5514418-01215947, dd) 5514418-01218564, ee) 5514418-01222489, ff) 5514418-01222812, gg) 5514418-01223831, hh) ii) 5514418-01228038, ii) 5514418-01228181, jj) 5514418-01230534, kk) 5514418-01235322, ll) 5514418-01236388, mm) 5514418-01244357, nn) 5514418-01250690, oo) 5514418-01250761, pp) 5514418-01256439; monitor, physiological, patient

Reason for Recall

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.

Distribution Pattern

Worldwide distribution.

Code Information

GTIN 00195278522313: a) 5514418, Serial Numbers: STZ22221001HA, STZ22230001HA, STZ22230002HA, STZ22230003HA, STZ22230004HA, STZ22230006HA, STZ22230007HA, STZ22230008HA, STZ22230009HA, STZ22230010HA, STZ22230011HA, STZ22230013HA, STZ22230014HA, STZ22230017HA, STZ22230018BP, STZ22230019HA, STZ22230020HA, STZ22230021HA, STZ22230022BP, STZ22230023HA, STZ22230024HA, STZ22230028HA, STZ22230029HA, STZ23140013HX, STZ23270003SA, STZ23360005SA, STZ23360008SA, STZ24020008SA, STZ24020009SA, STZ24020012SA; b) 5514418 / MAEP2, Serial Numbers: SU221320001HP, SU221320002HP, SU221320003HP, SU221320004HP, SU221320005HP, SU221320006HP, SU221320007HP, SU221320008HP, SU221320009HP, SU221320010HP, SU221320011HP, SU221320012HP, SU221320013HP, SU221320014HP, SU221320015HP, SU221320016HP, SU221320017HP, SU221320018HP, SU221320019HP, SU221320020HP, SU221320021HP, SU221320022HP, SU221320023HP, SU221320024HP, SU221320025HP, SU221320026HP, SU221320027HP, SU221320028HP, SU221320029HP, SU221320030HP, SU221320031HP, SU221320032HP, SU221320033HP, SU221320034HP, SU221320035HP, SU221320036HP, SU221320037HP, SU221320038HP, SU221320039HP, SU221320040HP; c) 5514418-01059642, Serial Numbers: STZ22230012HA, STZ22230015HA; d) 5514418-01080402, Serial Numbers: STZ22320001HA; e) 5514418-01081317, Serial Numbers: STZ22320009HA, STZ22320010HA, STZ22320011HA, STZ22320012HA, STZ22320013HA, STZ22320014HA; f) 5514418-01086007, Serial Numbers: STZ22230027HA; g) 5514418-01086838, Serial Numbers: STZ22320003HA, STZ22320004HA, STZ23310112HA, STZ23310113HA, STZ23310114HA, STZ23310123HA, STZ23310125HA, STZ23310126HA, STZ23310130HA, STZ23320158HA, STZ23320159HA, STZ23320160HA, STZ23320161HA, STZ23320162HA; h) 5514418-01088182, Serial Numbers: STZ22320006HA, STZ22320007HA; i) 5514418-01108442, Serial Numbers: STZ22220001HA, STZ22230016HA, STZ22230025HA, STZ22230026HA, STZ22320002HA, STZ22320005HA, STZ22320008HA, STZ22320015HA, STZ22320016HA, STZ22320017HA, STZ22320018HA, STZ22320019HA, STZ22320020HA, STZ22320021HA, STZ22320022HA, STZ22320023HA, STZ22320024HA, STZ22320025HA, STZ22320026HA, STZ22320028HA, STZ22320029HA; j) 5514418-01118673, Serial Numbers: STZ23120002HA, STZ23120003HA, STZ23120004HA, STZ23120005HA, STZ23120006HA, STZ23120007HA, STZ23120008HA, STZ23120009HA, STZ23120010HA, STZ23120011HA, STZ23120012HA; k) 5514418-01120764, Serial Numbers: STZ22320027HA; l) 5514418-01166521, Serial Numbers: STZ23190001HA, STZ23190002HA, STZ23190003HA, STZ23190004HA, STZ23190005HA, STZ23190006HA, STZ23190007HA, STZ23220001HA, STZ23220002HA, STZ23240012HA; m) 5514418-01180241, Serial Numbers: STZ23290053HA, STZ23290060HA, STZ23310067HA, STZ23310068HA, STZ23310070HA, STZ23310073HA, STZ23310075HA, STZ23310077HA, STZ23310078HA, STZ23310080HA, STZ23310081HA, STZ23310082HA, STZ23310084HA, STZ23310085HA, STZ23310086HA, STZ23310087HA, STZ23310088HA, STZ23310089HA, STZ23310091HA, STZ23310092HA, STZ23310094HA, STZ23310095HA, STZ23310096HA, STZ23310097HA, STZ23310099HA, STZ23310100HA, STZ23310102HA, STZ23310103HA, STZ23310104HA, STZ23310105HA, STZ23310106HA, STZ23310107HA, STZ23310108HA, STZ23310109HA, STZ23310111HA, STZ23310121HA, STZ23310127HA, STZ23310128HA, STZ23310129HA, STZ23310131HA, STZ23310134HA, STZ23310135HA, STZ23310136HA, STZ23310137HA, STZ23310139HA, STZ23310140HA, STZ23310142HA, STZ23310143HA, STZ23310144HA, STZ23320145HA, STZ23320146HA, STZ23320147HA, STZ23320150HA, STZ23320153HA, STZ23320154HA, STZ23320155HA, STZ23320156HA, STZ23320163HA, STZ23320164HA, STZ23320166HA, STZ23320167HA, STZ23320168HA, STZ23340200HA, STZ23340201HA, STZ23340202HA, STZ23340203HA, STZ23340204HA, STZ23380031HA, STZ23380032HA, STZ23380033HA, STZ23380034HA, STZ23380035HA, STZ23380036HA, STZ23380038HA, STZ23380039HA, STZ23380040HA, STZ23380041HA, STZ23380042HA, STZ23380044HA, STZ23380045HA, STZ23380046HA, STZ23380047HA; n) 5514418-01181177, Serial Numbers: STZ23240001HA, STZ23240007HA, STZ23240008HA, STZ23240002HA, STZ23240003HA, STZ23240004HA, STZ23240005HA, STZ23240006HA, STZ23240014HA, STZ23240015HA, STZ23240016HA, STZ23240017HA, STZ23240018HA, STZ23240019HA, STZ23240020HA, STZ23240021HA, STZ23240022HA, STZ23240023HA, STZ23240024HA, STZ23240026HA, STZ23240027HA; o) 5514418-01183037, Serial Numbers: STZ23240009HA, STZ23240010HA, STZ23240011HA, STZ23240013HA; p) 5514418-01184556, Serial Numbers: STZ23310071HA, STZ23310122HA, STZ23310132HA, STZ23310133HA, STZ23310138HA, STZ23310141HA, STZ23340187HA, STZ23340188HA, STZ23340189HA, STZ23340190HA, STZ23340191HA, STZ23340192HA, STZ23340195HA, STZ23340196HA, STZ23340197HA, STZ23340198HA, STZ23340217HA, STZ23340218HA, STZ23340219HA, STZ23340220HA, STZ23340221HA, STZ23340222HA; q) 5514418-01184557, Serial Numbers: STZ23310093HA, STZ23310098HA, STZ23310101HA, STZ23310110HA, STZ23310124HA; r) 5514418-01185805, Serial Numbers: STZ23290031HA, STZ23290032HA, STZ23290033HA, STZ23290034HA, STZ23290035HA, STZ23290036HA, STZ23290037HA, STZ23290038HA, STZ23290039HA, STZ23290040HA, STZ23290041HA, STZ23290042HA, STZ23290043HA, STZ23290044HA, STZ23290045HA, STZ23290046HA, STZ23290047HA, STZ23290048HA, STZ23290050HA, STZ23290051HA, STZ23290052HA, STZ23290055HA, STZ23290056HA, STZ23290057HA, STZ23290058HA, STZ23290059HA, STZ23290061HA, STZ23290062HA, STZ23290063HA, STZ23290064HA, STZ23290065HA, STZ23290066HA; s) 5514418-01186277, Serial Numbers: STZ23340179HA, STZ23340180HA, STZ23340181HA, STZ23340182HA, STZ23340183HA, STZ23340184HA, STZ23340185HA, STZ23340186HA, STZ23340211HA, STZ23340212HA, STZ23340213HA, STZ23340214HA, STZ23340215HA, STZ23340216HA; t) 5514418-01187473, Serial Numbers: STZ23310069HA, STZ23310072HA, STZ23310074HA, STZ23310076HA, STZ23310079HA, STZ23310083HA, STZ23310090HA, STZ23320148HA, STZ23320149HA, STZ23320151HA, STZ23320157HA, STZ23320165HA, STZ23320169HA, STZ23320170HA, STZ23320171HA, STZ23320172HA, STZ23320173HA, STZ24020007SA; u) 5514418-01188453, Serial Numbers: STZ23240025HA, STZ23320152HA; v) 5514418-01190677, Serial Numbers: STZ23290049HA, STZ23290054HA, STZ23390041HA, STZ23400006HA; w) 5514418-01192703, Serial Numbers: STZ23360015SA; x) 5514418-01192705, Serial Numbers: STZ23360013SA; y) 5514418-01203242, Serial Numbers: STZ23390030HA, STZ23390037HA, STZ23390038HA, STZ23390039HA, STZ23400001HA, STZ23400002HA, STZ23400003HA, STZ23400004HA, STZ23400005HA; z) 5514418-01206279, Serial Numbers: STZ23390016HA, STZ23360006SA, STZ23360010SA, STZ23360011SA, STZ23360012SA, STZ23360014SA, STZ23360016SA, STZ23360019SA, STZ23500002SA, STZ23510001SA, STZ23510002SA, STZ23510003SA, STZ23510004SA, STZ23510005SA, STZ23510006SA, STZ23510007SA, STZ23510008SA, STZ23510009SA, STZ23510010SA, STZ23510011SA, STZ23510012SA, STZ23510013SA, STZ23510020SA, STZ23510022SA, STZ23510024SA, STZ23510025SA, STZ23510026SA, STZ23510027SA, STZ23510028SA, STZ23510029SA, STZ23510030SA, STZ23510035SA, STZ23510036SA, STZ23510038SA, STZ23510039SA, STZ23510041SA, STZ23340193HA, STZ23340227HA, STZ23340228HA; aa) 5514418-01208248, Serial Numbers: STZ23340175HA, STZ23340176HA, STZ23340177HA, STZ23340178HA, STZ23340194HA, STZ23340205HA, STZ23340206HA, STZ23340207HA, STZ23340208HA, STZ23340209HA, STZ23340210HA; bb) 5514418-01212670, Serial Numbers: STZ23340223HA, STZ23340224HA, STZ23340225HA, STZ23340226HA; cc) 5514418-01215947, Serial Numbers: STZ23380001HA, STZ23380002HA, STZ23380003HA, STZ23380004HA, STZ23380005HA, STZ23380006HA, STZ23380007HA, STZ23380008HA, STZ23380009HA, STZ23380010HA, STZ23380011HA, STZ23380012HA, STZ23380013HA, STZ23380014HA, STZ23380015HA, STZ23380016HA, STZ23380017HA, STZ23380018HA, STZ23380019HA, STZ23380020HA, STZ23380021HA, STZ23380022HA, STZ23380023HA, STZ23380024HA, STZ23380025HA, STZ23380026HA, STZ23380027HA, STZ23380028HA, STZ23380029HA, STZ23380030HA, STZ23380049HA, STZ23380050HA, STZ23380051HA, STZ23380052HA, STZ23380053HA, STZ23380054HA, STZ23360007SA, STZ23360009SA, STZ23360017SA, STZ23360018SA, STZ23510014SA, STZ23510015SA, STZ23510016SA, STZ23510017SA, STZ23510018SA, STZ23510019SA, STZ23510021SA, STZ23510023SA, STZ23510031SA, STZ23510032SA, STZ23510033SA, STZ23510034SA, STZ23510037SA, STZ23510040SA, STZ24020026SA, STZ24020028SA, STZ24020033SA, STZ24020034SA, STZ24020035SA, STZ24020037SA, STZ24020039SA, STZ24020041SA, STZ24020042SA, STZ24040001SA, STZ24040002SA, STZ24040003SA, STZ24040004SA, STZ24040007SA; dd) 5514418-01218564, Serial Numbers: STZ23380037HA, STZ23380048HA; ee) 5514418-01222489, Serial Numbers: STZ23390013HA, STZ23390014HA, STZ23390015HA, STZ23390020HA, STZ23390021HA, STZ23390040HA; ff) 5514418-01222812, Serial Numbers: STZ23390031HA, STZ23390032HA, STZ23390036HA, STZ23390042HA; gg) 5514418-01223831, Serial Numbers: STZ23340199HA, STZ23380043HA, STZ23380055HA, STZ23380056HA, STZ23380057HA, STZ23390001HA, STZ23390002HA, STZ23390003HA, STZ23390004HA, STZ23390005HA, STZ23390006HA, STZ23390007HA, STZ23390008HA, STZ23390009HA, STZ23390010HA, STZ23390011HA, STZ23390012HA; hh) ii) 5514418-01228038, Serial Numbers: STZ23380058HA, STZ23380059HA, STZ23380060HA, STZ23390025HA, STZ23390026HA, STZ23390027HA, STZ23390028HA, STZ23390029HA, STZ23390033HA, STZ23390034HA, STZ23390035HA; ii) 5514418-01228181, Serial Numbers: STZ24040024SA; jj) 5514418-01230534, Serial Numbers: STZ24020006SA; kk) 5514418-01235322, Serial Numbers: STZ23390017HA; ll) 5514418-01236388, Serial Numbers: STZ23390018HA, STZ23390019HA, STZ23410001HA mm) 5514418-01244357, Serial Numbers: STZ23490001SA, STZ23490002SA; nn) 5514418-01250690, Serial Numbers: STZ24020004HA, STZ24020005HA, STZ24040001HA, STZ24040002HA, STZ24040003HA, STZ24040004HA, STZ24040005HA, STZ24040006HA, STZ24050002HA, STZ24050003HA, STZ24050004HA, STZ24050005HA, STZ24050006HA; oo) 5514418-01250761, Serial Numbers: STZ24010001SA, STZ24010002SA, STZ24010003SA, STZ24010004SA, STZ24010008SA, STZ24010009SA, STZ24010010SA, STZ24010011SA; pp) 5514418-01256439, Serial Numbers: STZ23390022HA, STZ24020006HA