Device product
CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
Z-2169-2024
Product summary
- Event
- Event 94494
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4649 units
- Official record key
device-enforcement:Z-2169-2024
Official wording
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.
Code information: 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
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
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.