Class 2 Device Recall GE Healthcare CARESCAPE

• Date Initiated by Firm: April 05, 2024
• Date Posted: June 21, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2169-2024
• Recall Event ID: 94494
• 510(K)Number: K223531
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
• 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
• Recalling Firm/ Manufacturer: GE Healthcare Finland Oy; Kuortaneenkatu 2; Helsinki Finland
• Manufacturer Reason for Recall: 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 Determined 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 in Commerce: 4649 units
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MHX