FDAClass IIJuly 3, 2024

CARESCAPE Canvas Smart Display recall

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

Why was CARESCAPE Canvas Smart Display 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
Recalling firm
GE Healthcare Finland Oy
Quantity
4649 units
Distribution
Worldwide distribution.
Recall date
July 3, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls