CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865770-01054698; f) 5865770-01054721; g) 5865770-01054740; h) 5865770-01055202; i) 5865770-01055204; j) 5865770-01055270; k) 5865770-01055317; l) 5865770-01055796; m) 5865770-01058501; n) 5865770-01058596; o) 5865770-01058597; p) 5865770-01059641; q) 5865770-01062146; r) 5865770-01065501; s) 5865770-01065702; t) 5865770-01065703; u) 5865770-01065739; v) 5865770-01065740; w) 5865770-01074051; x) 5865770-01074386; y) 5865770-01076001; z) 5865770-01077195; aa) 5865770-01077196; bb) 5865770-01079968; cc) 5865770-01080218; dd) 5865770-01080222; ee) 5865770-01080227; ff) 5865770-01080925; gg) 5865770-01080960; hh) 5865770-01081316; ii) 5865770-01081386; jj) 5865770-01083664; kk) 5865770-01085971; ll) 5865770-01086005; mm) 5865770-01086006; nn) 5865770-01086160; oo) 5865770-01086235; pp) 5865770-01086558; qq) 5865770-01086633; rr) 5865770-01086750; ss) 5865770-01087358; tt) 5865770-01087451; uu) 5865770-01087735; vv) 5865770-01088176; ww) 5865770-01088803; xx) 5865770-01090156; yy) 5865770-01090457; zz) 5865770-01090462; aaa) 5865770-01090480; bbb) 5865770-01090911; ccc) 5865770-01092697; ddd) 5865770-01093133; eee) 5865770-01093401; fff) 5865770-01093490; ggg) 5865770-01093491; hhh) 5865770-01093512; iii) 5865770-01093911; jjj) 5865770-01093963; kkk) 5865770-01095002; lll) 5865770-01095003; mmm) 5865770-01095004; nnn) 5865770-01095722; ooo) 5865770-01096224; ppp) 5865770-01096505; qqq) 5865770-01096507; rrr) 5865770-01097422; sss) 5865770-01097466; ttt) 5865770-01097605; uuu) 5865770-01097608; vvv) 5865770-01097609; www) 5865770-01098100; xxx) 5865770-01098101; yyy) 5865770-01098149; zzz) 5865770-01098152; aaaa) 5865770-01098554; bbbb) 5865770-01098564; cccc) 5865770-01098839; dddd) 5865770-01099430; eeee) 5865770-01099480; ffff) 5865770-01099958; gggg) 5865770-01101532; hhhh) 5865770-01103577; iiii) 5865770-01104960; jjjj) 5865770-01105370; kkkk) 5865770-01105397; llll) 5865770-01105426; mmmm) 5865770-01106057; nnnn) 5865770-01106058; oooo) 5865770-01106063; pppp) 5865770-01106392; qqqq) 5865770-01106395; rrrr) 5865770-01106785; ssss) 5865770-01107872; tttt) 5865770-01108428; uuuu) 5865770-01108437; vvvv) 5865770-01108439; wwww) 5865770-01108440; xxxx) 5865770-01108441; yyyy) 5865770-01108729; zzzz) 5865770-01108744; aaaaa) 5865770-01108785; bbbbb) 5865770-01109135; ccccc) 5865770-01109863; ddddd) 5865770-01110047; eeeee) 5865770-01110383; fffff) 5865770-01110384; ggggg) 5865770-01111086; hhhhh) 5865770-01111116; iiiii) 5865770-01111405; jjjjj) 5865770-01112307; kkkkk) 5865770-01112781; lllll) 5865770-01112852; mmmmm) 5865770-01113283; nnnnn) 5865770-01114755; ooooo) 5865770-01115277; ppppp) 5865770-01115278; qqqqq) 5865770-01115283; rrrrr) 5865770-01115304; sssss) 5865770-01115637; ttttt) 5865770-01118674; uuuuu) 5865770-01119976; vvvvv) 5865770-01120050; wwwww) 5865770-01120073; xxxxx) 5865770-01120763; yyyyy) 5865770-01121267; zzzzz) 5865770-01122511; aaaaaa) 5865770-01122678; bbbbbb) 5865770-01123105; cccccc) 5865770-01123107; dddddd) 5865770-01123128; eeeeee) 5865770-01123423; ffffff) 5865770-01123424; gggggg) 5865770-01123482; hhhhhh) 5865770-01123508; iiiiii) 5865770-01123510; jjjjjj) 5865770-01123540; kkkkkk) 5865770-01123543; llllll) 5865770-01123953; mmmmmm) 5865770-01124296; nnnnnn) 5865770-01125177; oooooo) 5865770-01125584; pppppp) 5865770-01125799; qqqqqq) 5865770-01125800; rrrrrr) 5865770-01125801; ssssss) 5865770-01127406; tttttt) 5865770-01127432; uuuuuu) 5865770-01127433; vvvvvv) 5865770-01128035; wwwwww) 5865770-01128294; xxxxxx) 5865770-01128706; yyyyyy) 5865770-01128708; zzzzzz) 5865770-01130685; aaaaaaa) 5865770-01131742; bbbbbbb) 5865770-01132411; ccccccc) 5865770-01132561; ddddddd) 5865770-01132625; eeeeeee) 5865770-01133378; fffffff
Publicado el 3 de julio de 2024 · Inicio del retiro: 5 de abril de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare Finland Oy
- Distribuidor
- Worldwide distribution.
- Lote
- GTIN 00195278522320: a) 5865770, Serial Numbers: STN22230004HA, STN22390002HA, STN22390006HA, STN22390007HA, STN22520051HA, STN23170167HA, STN23290382HA, STN23500120HA, STN24030033HA, STN24050016HA, STN23270003SA, STN24100007SA; b) 5865770-01040169, Serial Numbers: STN22230005HA, STN22230010HA, STN22230020HA, STN22230023HA, STN22230024HA; c) 5865770-01054142, Serial Numbers: STN22290004HA, STN22290005HA, STN22290006HA, STN22290007HA, STN22290008HA, STN22290009HA, STN22290010HA, STN22290011HA, STN22290013HA, STN22290014HA, STN22290015HA, STN22290016HA, STN22290058HA, STN22290059HA, STN22290060HA, STN22300005HA, STN22300006HA, STN22300010HA, STN22300011HA, STN22300012HA, STN22300013HA, STN22300014HA, STN22300015HA, STN22300072HA, STN22300073HA, STN22300074HA, STN22300075HA, STN22300076HA, STN22300077HA; d) 5865770-01054696, Serial Numbers: STN22340026HA, STN22340028HA, STN22340029HA, STN22340031HA, STN22340032HA, STN22340033HA, STN22340034HA; e) 5865770-01054698, Serial Numbers: STN22340007HA, STN22340020HA, STN22340021HA, STN22340022HA, STN22340023HA, STN22340024HA, STN22340036HA, STN22340037HA, STN22340038HA, STN22340039HA, STN22340040HA, STN22340043HA, STN22360001HA, STN22360002HA, STN22360003HA, STN22360078HA, STN22360080HA, STN22360081HA, STN22370001HA, STN22370002HA, STN22340050HA; f) 5865770-01054721, Serial Numbers: STN22230009HA, STN22230011HA, STN22230012HA, STN22230016HA, STN22230021HA, STN22230022HA, STN22230029HA; g) 5865770-01054740, Serial Numbers: STN22290027HA, STN22290030HA, STN22290031HA, STN22290032HA, STN22290033HA, STN22290034HA, STN22290035HA, STN22290042HA, STN22290044HA, STN22290045HA, STN22290047HA, STN22290048HA, STN22290049HA, STN22290050HA, STN22290051HA, STN22290053HA, STN22300036HA, STN22300060HA, STN22330005HA, STN22330006HA, STN22330007HA; h) 5865770-01055202, Serial Numbers: STN22270004HA, STN22270005HA, STN22270011HA, STN22270012HA, STN22270013HA, STN22270014HA, STN22270015HA, STN22270016HA, STN22270017HA, STN22270019HA, STN22270020HA, STN22280001HA, STN22280002HA, STN22280016HA, STN22280017HA, STN22280018HA, STN22280019HA, STN22280020HA, STN22280022HA, STN22280023HA, STN22280024HA, STN22280025HA, STN22280026HA, STN22280028HA, STN22410096HA, STN22410097HA, STN22410109HA, STN22410110HA, STN22410111HA, STN22410112HA, STN22410113HA, STN22410115HA, STN22410117HA, STN22410119HA, STN22410120HA, STN22410121HA, STN22410122HA, STN22410123HA, STN22410124HA, STN22410125HA, STN22410126HA, STN22410127HA, STN22410128HA, STN22410129HA, STN22410130HA, STN22410131HA, STN22410132HA, STN22410133HA, STN22410134HA, STN22410135HA, STN22410150HA, STN22410151HA, STN22270007HA, STN22270018HA; i) 5865770-01055204, Serial Numbers: STN22410065HA, STN22410066HA, STN22410067HA, STN22410068HA, STN22410069HA, STN22410070HA, STN22410071HA, STN22410072HA, STN22410074HA, STN22410075HA, STN22410076HA, STN22410077HA, STN22410082HA, STN22410083HA, STN22220001HA, STN22230002HA, STN22230003HA, STN22230006HA, STN22230007HA, STN22230008HA, STN22230013HA, STN22230014HA, STN22230015HA, STN22230017HA, STN22230019HA, STN22230025HA, STN22230026HA, STN22230027HA, STN22230030HA, STN22270001HA, STN22270002HA, STN22270003HA, STN22270006HA, STN22270010HA, STN22410098HA, STN22410100HA, STN22410101HA, STN22410102HA, STN22410103HA, STN22410104HA, STN22410105HA, STN22410106HA, STN22410107HA, STN22410108HA, STN22230018HA, STN22270008HA; j) 5865770-01055270, Serial Numbers: STN22360074HA, STN22410001HA, STN22410002HA, STN22410003HA, STN22410004HA, STN22410006HA, STN22410007HA, STN22410008HA, STN22410009HA, STN22410010HA, STN22410011HA, STN22410012HA, STN22410015HA, STN22410016HA, STN22410017HA, STN22410018HA, STN22410019HA, STN22410020HA, STN22410021HA, STN22410022HA, STN22410023HA, STN22410024HA, STN22410025HA, STN22410027HA, STN22410028HA, STN22410029HA, STN22410030HA, STN22410031HA, STN22410032HA, STN22410033HA, STN22410034HA, STN22410035HA, STN22410036HA, STN22410037HA, STN22410038HA, STN22410039HA, STN22410040HA, STN2
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Finland
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