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CARESCAPE Canvas Smart Display, Model Numbers recallZ-2170-2024 · GE Healthcare Finland Oy · initiated Apr 5, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Healthcare Finland Oy or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

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].

Recall details

Recall number
Z-2170-2024
Status
Open, Classified
Initiated by the company
Apr 5, 2024
Posted by the FDA
Jun 21, 2024
Recalling firm
GE Healthcare Finland Oy
Quantity
547 units
Product code
MHX
FDA submissions
K191323, K213336
Distribution
Worldwide distribution.

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

Code information (models, lots, serial numbers)

Show the full code information (10k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

2 devices cleared under K191323, K213336 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94494).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page