GE Healthcare Finland Oy: CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient

Recall number

Z-2169-2024

Recalling firm

GE Healthcare Finland Oy

Product

CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient

Status

Open, Classified

Initiated

2024-04-05

Posted

2024-06-21

Terminated

not on file

Reason

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

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 FMI.36161@gehealthcare.com.

Quantity

4649 units

Distribution

Worldwide distribution.

Lot, serial or model codes

GTIN 00195278522313: a) 5700023, Serial Numbers: 2534526-3-1, 2553213-5-1, 2606854-2-1, 5220256-1-1, 5215673-1-1, 5215634-1-1, 5264236-1-1, 5264113-1-1, 5245953-1-1, 5264089-1-1, 5275734-1-1, 5301535-1-1, 5300969-1-1, 5341313-1-1, 5395275-1-1, 5232613-1-1, 5232595-1-1, 5287222-1-1, 5390098-3-1, 5316614-6-1, 5316614-16-1, 5316614-22-1, 2615004-27-1, 5368586-1-1, 5223040-1-1, 5223040-1-2, 5223040-1-3, 5223040-1-4, 5274472-12-1, 5274472-71-1, 5350377-1-1, 5215675-1-1, 5223119-1-1, 5231395-1-1, 5245547-1-1, 5307272-2-1, 5318051-3-1, 5318978-2-1, 5317879-3-1, 5331606-1-1, 5338491-2-1, 5356848-4-1, 5356848-8-1, 5356848-7-1, 5356848-10-1, 5365520-6-1, 5373002-3-1, 5356866-18-1, 5356866-10-1, 5356866-26-1, 5356866-6-1, 5356866-2-1, 5374179-2-1, 2495499-1-1, 2495362-1-1, 2514941-1-1, 2522522-1-1, 2525199-1-1, 2520809-1-1, 2520809-1-2, 2526133-1-1, 2503865-2-1, 2514269-1-1, 2532289-1-1, 2534398-6-1, 2543443-1-1, 2538968-1-1, 2543938-15-1, 2547020-1-1, 2556233-14-1, 2556233-13-1, 2607079-5-1, 2556233-18-1, 2494479-1-1, 2494484-1-1, 2494487-1-1, 2515199-1-1, 2494485-1-1, 2494483-1-1, 2512827-1-1, 2512885-1-1, 2513077-1-1, 2518278-4-1, 2531556-1-1, 2525641-2-1, 2554943-1-1, 2551434-1-1, 2582151-1-1, 2585668-6-1, 2611315-1-1, 2611294-1-1, 2564890-3-1, 2619057-1-1, 2617112-1-1, 2618012-4-1, 2494648-5-1, 2500341-1-1, 2500318-2-1, 2509366-1-1, 2509367-1-1, 2512604-1-1, 2512604-1-2, 2514892-1-1, 2513939-2-1, 2516853-1-1, 2516851-1-1, 2523820-1-1, 2523643-2-1, 2524982-5-1, 2524982-1-1, 2537780-1-1, 2537780-1-2, 2522678-7-1, 2556763-18-1, 2556763-2-1, 2556763-18-2, 2562037-1-1, 2555090-2-1, 2576242-2-1, 2576259-2-1, 2554602-1-1, 2560382-1-1, 2560381-1-1, 2586284-1-1, 2612355-1-1, 2610438-1-1, 2611840-3-1, 2611351-2-1, 2611541-1-1, 2612895-4-1, 2604783-2-1, 2618900-1-1, 2618900-1-2, 2622551-1-1, 2623858-3-1, 2623105-1-1, 2623105-1-2, 2624426-2-1, 2626536-1-1, 2494497-1-1, 2494500-1-1, 2494525-1-1, 2503234-1-1, 2494526-1-1, 2495361-1-1, 2496099-1-1, 2516274-1-1, 2514690-1-1, 2495543-1-1, 2495400-1-1, 2495559-1-1, 2495409-1-1, 2519427-1-1, 2519427-1-2, 2519427-1-3, 2503764-1-1, 2522006-1-1, 2513114-3-1, 2514141-1-1, 2521852-1-1, 2512685-1-1, 2521540-1-1, 2522959-1-1, 2522761-1-1, 2519916-11-1, 2529981-1-1, 2529405-12-1, 2529406-11-1, 2529982-1-1, 2529409-9-1, 2529409-6-1, 2529434-1-1, 2543934-7-1, 2543933-7-1, 2543932-1-1, 2539102-7-1, 2539094-7-1, 2539436-1-1, 2540128-1-1, 2539084-8-1, 2539437-1-1, 2539438-1-1, 2528671-18-1, 2562722-1-1, 2568082-1-1, 2554514-1-1, 2547282-20-1, 2547282-6-1, 2547282-10-1, 2547282-8-1, 2547282-4-1, 2547231-10-1, 2547446-15-1, 2523479-16-1, 2552470-1-1, 2580467-1-1, 2561965-1-1, 2582525-6-1, 2582525-32-1, 2585579-2-1, 2592273-1-1, 2599020-1-1, 2579706-5-1, 2574524-13-1, 2562789-9-1, 2562789-2-1, 2562789-9-2, 2562789-5-1, 2562789-5-2, 2562789-4-1, 2562789-2-3, 2562789-37-1, 2562789-18-1, 2562789-14-1, 2562789-20-1, 2579723-1-1, 2580465-2-1, 2567049-24-1, 2580465-12-1, 2554559-19-1, 2604759-1-1, 2606427-1-1, 2575662-15-1, 2582438-1-1, 2612551-1-1, 2574524-13-2, 2611203-1-1, 2612612-10-1, 2611747-1-1, 2606474-1-1, 2611016-1-1, 2612734-18-1, 2612734-2-1, 2613185-15-1, 2613083-1-1, 2615930-1-1, 2613111-1-1, 2613111-20-1, 2618898-2-1, 2617993-2-1, 2617993-1-1, 2615926-1-1, 2616599-1-1, 2618691-30-1, 2616077-1-1, 2618690-20-1, 2621975-1-1, 2618903-10-1, 2622941-1-1, 2619537-1-1, 2621988-1-1, 2622940-1-1, 2620603-1-1, 2619182-2-1, 2625896-1-1, 2624865-1-1, 2624047-1-1, 2626740-2-1, 2624450-1-1, 2624725-18-1, 2624725-13-1, 2624725-5-1, 2624725-1-1, 2624725-13-2, 2577660-1-1, 2517501-1-1, 2545870-1-1, 2615937-3-1, 2616596-2-1, 2619984-2-1, 2616737-1-1, 2618481-5-1, 2499911-1-1, 2505712-1-1, 2503687-1-1, 2554926-1-1, 2572230-2-1, 2588785-1-1, 2495298-1-1, 2495264-1-1, 2509179-2-1, 2495358-1-1, 2515181-2-1, 2515181-1-1, 2513165-1-1, 2495299-1-1, 2531550-1-1, 2544853-2-1, 2574647-2-1, 2598884-1-1, 2618137-1-1, 2628573-1-1, 2494372-1-1, 2518561-9-1, 2522026-1-1, 2522834-1-1, 2524986-1-1, 2524986-7-1, 2524898-1-1, 2522845-1-1, 2529643-1-1, 2543789-1-1, 2552218-1-1, 2552156-1-1, 2552158-1-1, 2551090-7-1, 2557045-1-1, 2556176-13-1, 2571940-4-1, 2569835-2-1, 2574703-4-1, 2584917-4-1, 2595848-2-1, 2604561-1-1, 2604556-1-1, 2605946-1-1, 2605946-1-2, 2605946-1-3, 2605946-1-4, 2609030-1-1, 2611696-1-1, 2613465-1-1, 2612021-1-1, 2617132-1-1, 2616584-1-1, 2616584-1-2, 2619512-1-1, 2619506-1-1, 2618910-4-1, 2620627-1-1, 2620625-1-1, 2620672-1-1, 2619873-2-1, 2620665-1-1, 2619880-1-1, 2620617-1-1, 2620610-1-1, 2620667-1-1, 2620184-1-1, 2620624-3-1, 2620185-1-1, 2624861-1-1, 2625758-1-1, 2625946-1-1, 5365928-16-1, 2556663-2-1, 2556714-2-1, 5227069-1-1, 5272630-1-1, 5323410-2-1, 5363045-26-1, 2495391-1-1, 2495391-1-2, 2495390-1-1, 2495390-1-2, 2495390-1-3, 2495390-1-4, 2495391-1-3, 2495391-1-4, 2495388-2-1, 2521107-1-1, 2529146-1-1, 2546098-1-1, 2547269-1-1, 2547722-1-1, 2539431-1-1, 2547016-1-1, 2616640-1-1, 2620989-1-1, 2621646-1-1, 2618162-1-1, 2514419-2-1, 2514419-2-2, 5206450-1-1, 5154318-1-1, 5154276-1-1, 5206443-1-1, 5222668-1-1, 5300958-1-1, 5313048-22-1, 5313048-62-1, 5346596-31-1, 5344117-1-1, 5341616-12-1, 5341619-10-1, 2497074-1-1, 2515206-1-1, 2522537-1-1, 2515205-1-1, 2531024-2-1, 2531024-1-1, 2531180-1-1, 2551366-1-1, 2556063-4-1, 2534343-13-1, 2534343-17-1, 2532125-45-1, 2574438-1-1, 2589300-1-1, 2589311-1-1, 2589312-1-1, 2589301-1-1, 2589308-1-1, 2589309-1-1, 2578226-1-1, 2600361-23-1, 2586763-1-1, 2573863-2-1, 2586760-1-1, 2595286-1-1, 2586318-1-1, 2589302-1-1, 2589520-1-1, 2589511-1-1, 2586757-1-1, 2586753-1-1, 2586729-1-1, 2586734-1-1, 2586762-1-1, 2586752-1-1, 2605396-1-1, 2605342-1-1, 2605929-1-1, 2605935-1-1, 2605989-1-1, 2605951-1-1, 2610744-1-1, 2610826-18-1, 2610826-10-1, 2607292-1-1, 2608880-2-1, 2609315-1-1, 2609592-5-1, 2609559-1-1, 2609691-3-1, 2609340-1-1, 2609585-1-1, 2609334-1-1, 2609586-1-1, 2609350-1-1, 2609588-1-1, 2623578-16-1, 2622019-1-1, 2622025-1-1, 2622573-7-1, 2622573-27-1, 2622955-8-1, 2628534-3-1, 2628533-4-1, 2625902-6-1, 2495410-1-1, 2515674-1-1, 2514790-1-1, 2514715-1-1, 2515509-1-1, 2517461-1-1, 2519722-11-1, 2517647-1-1, 2516443-6-1, 2549822-22-1, 2549680-1-1, 2554101-1-1, 2562362-2-1, 2562825-4-1, 2571502-8-1, 2570126-2-1, 2577337-1-1, 2583607-6-1, 2570194-15-1, 2600414-14-1, 2605924-1-1, 2601688-1-1, 2601655-1-1, 2601803-1-1, 2611874-2-1, 2601748-1-1, 2601940-1-1, 2592691-6-1, 2592820-8-1, 2592691-7-1, 2592820-6-1, 2601920-1-1, 2613980-6-1, 2609421-4-1, 2601846-1-1, 2614641-11-1, 2610892-1-1, 2608694-2-1, 2615575-12-1, 2614969-22-1, 2615764-5-1, 2599224-2-1, 2621236-1-1, 2616938-3-1, 2616938-3-2, 2618511-6-1, 2624560-1-1, 2623606-5-1, 2626368-1-1, 2626370-1-1, 2626712-1-1, 2622224-9-1, 2623632-2-1, 2627177-8-1, 2623632-2-2, 2623632-2-3, 2627168-1-1, 2627801-36-1, 2628801-1-1, 2627695-9-1, 2626721-1-1, 2627175-2-1, 2627174-1-1, 2628301-1-1, 2509816-1-1, 2514797-1-1, 2517806-1-1, 2523476-1-1, 2523477-6-1, 2519756-3-1, 2520861-2-1, 2519763-4-1, 2519774-5-1, 2520365-3-1, 2519758-3-1, 2519758-5-1, 2523326-1-1, 2514456-4-1, 2524713-3-1, 2519512-1-1, 2519512-1-2, 2519512-1-3, 2528982-1-1, 2523876-4-1, 2525226-3-1, 2523871-1-1, 2523841-2-1, 2534939-1-1, 2524913-3-1, 2531974-1-1, 2533581-1-1, 2539845-3-1, 2537914-1-1, 2539820-8-1, 2535298-1-1, 2521153-4-1, 2536270-6-1, 2530263-5-1, 2530263-5-2, 2530263-1-1, 2560347-8-1, 2554261-6-1, 2554486-6-1, 2553619-8-1, 2553619-9-1, 2528652-7-1, 2528652-6-1, 2528652-9-1, 2576457-2-1, 2549815-32-1, 2549815-7-1, 2624547-1-1; b) 5700023-02, Serial Numbers: 5376661-1-1, 5376661-1-2, 5352820-3-1, 5266636-23-1, 5232164-5-1, 5232164-5-2, 5232640-38-1, 5232640-38-2, 5263649-44-1, 5233325-1-1, 5233325-1-2, 5263648-6-1, 5263648-6-2, 5263643-8-1, 5263646-12-1, 5261241-2-1, 5263645-19-1, 5263644-24-1, 4920193-12-1, 5296964-13-1, 5392029-1-1, 4861348-9-1, 5231103-28-1, 5231100-20-1, 5231106-2-1, 5231106-4-1, 5231104-39-1, 5231101-16-1, 5231102-4-1, 5231102-19-1, 5296738-19-1, 5296738-5-1, 5296738-1-1, 5296738-1-2, 5296738-4-1, 5231104-1-1, 5296738-35-1, 5354648-1-1, 5320993-14-1, 5320993-11-1.5320993-44-1, 5097227-1-1, 5297079-14-1, 5335889-23-1, 5344243-4-1, 5344243-2-1, 5347576-2-1, 5359061-1-1, 5344696-1-1, 5288824-12-1, 5290581-5-1, 5272370-30-1, 5316921-1-1, 5233767-3-1, 5233767-2-1, 5252009-2-1, 5233165-47-1, 5377507-9-1, 5244310-2-1, 5251994-11-1, 5255034-4-1, 5255034-4-2, 5226930-18-1, 5241745-8-1, 5226930-4-1, 5226935-12-1, 5262866-2-1, 5262866-3-1, 5363729-19-1, 5212009-18-1, 5233042-24-1, 5233042-40-1, 5355390-3-1, 5291738-20-1, 5329207-2-1, 5354793-4-1, 5365513-18-1, 5368489-4-1, 5368492-13-1, 5318209-4-1, 5318202-11-1, 5318202-5-1, 5316711-13-1, 5316740-4-1, 5318188-15-1, 5316734-15-1, 5349390-3-1, 5374225-1-1, 5368169-34-1, 5368473-17-1, 5285417-4-1, 5354298-11-1, 5326282-8-1, 5330973-7-1, 5330973-3-1, 5361980-2-1, 5362007-54-1, 5232017-4-1, 5232017-4-2, 5300447-4-1, 5300278-4-1, 5300288-20-1, 5300295-12-1, 5338568-9-1, 5349366-1-1, 5349366-19-1, 5317581-29-1, 5331910-2-1, 5269037-8-1, 5269031-12-1, 5269015-25-1, 5028206-13-1, 5028206-13-2, 5169978-44-1, 5169997-44-1, 5169986-44-1, 5169950-1-1, 5364842-14-1, 5364842-3-1, 5262625-3-1, 5262623-80-1, 5374700-1-1, 5307843-20-1, 5371929-2-1, 5363162-10-1, 5356362-4-1, 5289111-19-1, 5353247-2-1, 5312936-16-1, 5312936-3-1, 5382031-1-1, 5382031-17-1, 5226855-3-1, 5292685-1-1, 5298493-13-1, 5298493-11-1, 5332148-3-1, 5332161-1-1, 5258798-11-1, 5258875-26-1, 5392201-1-1, 5392201-1-2, 5253414-1-1, 5331912-11-1, 5377458-1-1, 5336622-44-1, 5249468-2-1, 5249468-18-1, 5249458-15-1, 5249458-16-1, 5249669-13-1, 5249669-12-1, 2563777-1-1, 5353311-4-1, 5326776-1-1, 5223229-24-1, 5268496-9-1, 5267840-11-1, 5267840-13-1, 5268563-4-1, 5268563-2-1, 5268639-39-1, 5267932-24-1, 5271180-24-1, 5271522-24-1, 5356417-15-1, 5267884-24-1, 5373465-1-1, 5198791-1-1, 5266773-23-1, 5194983-1-1, 5194895-1-1, 5195392-1-1, 5194918-1-1, 5194589-1-1, 5390240-1-1, 5321832-50-1, 5250118-2-1, 2561736-1-1, 2561737-1-1, 2561738-1-1, 2575685-1-1, 5249743-1-1, 5250027-1-1, 5267969-1-1, 5250030-12-1, 5249745-1-1, 5284445-1-1, 5332331-1-1, 5249517-21-1, 5249592-1-1, 5250034-25-1, 5250032-16-1, 5307523-1-1, 5250130-1-1, 5250035-1-1, 5332362-1-1, 5336708-6-1, 5336708-14-1, 5332350-10-1, 2583232-1-1, 2588852-3-1; c) 5939590-102, Serial Numbers: 5377458-33377-240125A

510(k) numbers

["K223531"]

PMA numbers

not on file

Product code

MHX

Firm FEI

3002806783

Firm city

Helsinki

Firm state

not on file

Firm country

Finland

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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