Z-2170-2024Class II

CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d)...

Name: Z-2170-2024 CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d)...
Creator: GE Healthcare Finland Oy
Published: 2024-04-05
License: https://open.fda.gov/license/

GE Healthcare Finland Oy / initiated 2024-04-05 / Open, Classified / root cause: software

FDA source

GE Healthcare Finland Oy began a recall of CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-01081317, f)... on 2024-04-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2170-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-05
Posted: 2024-06-21
Recalling firm: GE Healthcare Finland Oy
Product: 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
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: software
FDA root cause: Software design
Action: GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 04/05/2024 via *****. The notice explained the problem with the device, potential risk, and requested the following actions to be taken by Customer/User: 1. You can continue to use your monitor if the CPU timekeeper battery has not been replaced. If the monitor has had a CPU timekeeper battery replaced or if you are unsure whether the CPU timekeeper battery was replaced, reinstall the host software using the software media that is included as part of the equipment. 2. In the event the monitor does not start up following a mains power loss during active monitoring, continue patient assessment with other methods until a replacement monitor or display has been connected. 3. Update any facility planned maintenance schedules to remove CPU timekeeper battery replacement. Only change the battery if "Service Monitor Error Code 0xHOST1100" error message occurs. After changing the battery, reinstall the host software using the host software media that is included as part of the equipment. 4. Download the full User manual documentation set which contains the revised Service and Supplemental Information Manual(s) from the GE HealthCare Customer Documentation Portal. See Appendix for a list of updated and impacted part numbers. https://www.gehealthcare.com/support/manuals If you have difficulty accessing the documentation, please contact GE HealthCare for assistance. 5. Discontinue usage and destroy and/or delete all impacted versions of the Service Manuals, Supplemental Information Manuals and delivery media. 6. Complete and return the attached Acknowledgement Form to [email protected].
Quantity in commerce: 547 units
Distribution: Worldwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2170-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2168-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-21
Z-2169-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-21
Z-2170-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-21
Z-2171-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-21
Z-2172-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-21

Product code MHX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)