{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-07-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Ongoing", "city": "Helsinki", "state": "", "country": "Finland", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "94494", "recalling_firm": "GE Healthcare Finland Oy", "address_1": "Kuortaneenkatu 2", "address_2": "", "postal_code": "N/A", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide distribution.", "recall_number": "Z-2170-2024", "product_description": "CARESCAPE Canvas Smart Display, Model Numbers: a)\t5514418, b)\t5514418 / MAEP2, c)\t5514418-01059642, d)\t5514418-01080402, e)\t5514418-01081317, f)\t5514418-01086007, g)\t5514418-01086838, h)\t5514418-01088182, i)\t5514418-01108442, j)\t5514418-01118673, k)\t5514418-01120764, l)\t5514418-01166521, m)\t5514418-01180241, n)\t5514418-01181177, o)\t5514418-01183037, p)\t5514418-01184556, q)\t5514418-01184557, r)\t5514418-01185805, s)\t5514418-01186277, t)\t5514418-01187473, u)\t5514418-01188453, v)\t5514418-01190677, w)\t5514418-01192703, x)\t5514418-01192705, y)\t5514418-01203242, z)\t5514418-01206279, aa)\t5514418-01208248, bb)\t5514418-01212670, cc)\t5514418-01215947, dd)\t5514418-01218564, ee)\t5514418-01222489, ff)\t5514418-01222812, gg)\t5514418-01223831, hh)\tii)\t5514418-01228038, ii)\t5514418-01228181, jj)\t5514418-01230534, kk)\t5514418-01235322, ll)\t5514418-01236388, mm)\t5514418-01244357, nn)\t5514418-01250690, oo)\t5514418-01250761, pp)\t5514418-01256439; monitor, physiological, patient", "product_quantity": "547 units", "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.", "recall_initiation_date": "20240405", "center_classification_date": "20240621", "report_date": "20240703", "code_info": "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", "more_code_info": "" } ] }