GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
Brand
GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland
Lot Codes / Batch Numbers
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, 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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
Products Sold
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, 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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
GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland is recalling CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monit due to GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026