FDA-Device2024-07-03Class II
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) 5865
GE Healthcare Finland Oy
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.
Sold states
Worldwide distribution.
Affected count
9267 units
Manufactured in
Kuortaneenkatu 2, Helsinki, Finland
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2168-2024Don't want to check this manually?
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