{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216227", "product_res_number": "Z-0213-2026", "event_date_initiated": "2025-09-05", "event_date_posted": "2025-10-21", "recall_status": "Open, Classified", "res_event_number": "97646", "product_code": "DXJ", "k_numbers": [ "K162012" ], "product_description": "GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube", "code_info": "GTIN 00195278343512, Serial Numbers: STU25210418SA, STU25210417SA, STU25210419SA, STU25250440SA, STU25250439SA, STU25260447SA, STU25210407SA, STU25210406SA, STU24200003SA, STU24200006SA, STU24200005SA, STU24200004SA, STU23240015SA, STU24240019SA, STU24240020SA, STU24240007SA, STU24240022SA, STU24240021SA, STU24330020SA, STU24240014SA, STU24240013SA, STU24330019SA, STU24330022SA, STU24330016SA, STU24240005SA, STU24240008SA, STU24240012SA, STU24330018SA, STU24330021SA, STU24330017SA, STU23160011SA, STU23240007SA, STU24310001SA, STU25210433SA, STU25210432SA, STU25200390SA, STU25200392SA, STU25200391SA, STU25200399SA, STU25200397SA, STU25200395SA, STU25200393SA, STU25200398SA, STU25200396SA, STU25250438SA, STU25270475SA, STU25270456SA, STU25270468SA, STU25270458SA, STU25270466SA, STU25270476SA, STU25270469SA, STU25270473SA, STU25270459SA, STU25270474SA, STU25270467SA, STU25210430SA, STU25210429SA, STU25180343SA, STU25190347SA, STU25190348SA, STU24200007SA, STU25190360SA, STU25240436SA, STU25190361SA, STU25190362SA, STU25190363SA, STU25240437SA, STU25190359SA, STU24510027SA, STU24510032SA, STU24510010SA, STU24510020SA, STU24510017SA, STU24510026SA, STU24510018SA, STU24510024SA, STU24510025SA, STU24510031SA, STU24510011SA, STU24510029SA, STU24510023SA, STU24510030SA, STU24510021SA, STU24510019SA, STU24510022SA, STU25190350SA, STU25200388SA, STU25200389SA, STU25210412SA, STU25190349SA, STU25190381SA, STU25190376SA, STU25190383SA, STU25190374SA, STU25190367SA, STU25190372SA, STU25190379SA, STU25190368SA, STU25190352SA, STU25190358SA, STU25190370SA, STU25190366SA, STU25190355SA, STU25190354SA, STU25190382SA, STU25190380SA, STU25190371SA, STU25190377SA, STU25190353SA, STU25190351SA, STU25190364SA, STU25190357SA, STU25190384SA, STU25190369SA, STU25190373SA, STU25190356SA, STU25190365SA, STU25190378SA, STU25190385SA, STU25210410SA, STU25210411SA, STU25210409SA, STU25230435SA, STU25180346SA, STU25180344SA, STU25180345SA, STU25210413SA, STU25210414SA, STU25210423SA, STU25210431SA, STU25210415SA, STU25270453SA, STU25260450SA, STU25260451SA, STU25290488SA, STU25210408SA, STU25210400SA, STU25270454SA, STU25210404SA, STU25210421SA, STU25270464SA, STU25210420SA, STU25270462SA, STU25210425SA, STU25270461SA, STU25210426SA, STU25210428SA, STU25210427SA, STU25270463SA, STU25270460SA, STU24460058SA, STU24460059SA, STU24460071SA, STU24460060SA, STU25200387SA, STU25210401SA, STU25200386SA, STU25210424SA, STU25270457SA, STU25270465SA, STU25300492SA, STU25210402SA, STU25210403SA, STU25250446SA, STU25210422SA, STU25210405SA, STU25260449SA, STU25290481SA, STU25290482SA, STU25290483SA, STU25290484SA, STU25210416SA.", "firm_fei_number": "3007734888", "recalling_firm": "Wipro GE Healthcare Private Ltd.", "address_1": "122 Part 1 1 odyssey and galileo part", "city": "Bengaluru", "country": "India", "additional_info_contact": "GE HealthCare Service\n800-437-1171", "reason_for_recall": "Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.", "root_cause_description": "Software design", "action": "GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 09/05/2025, by letter delivered via traceable means. The notice explained the issues and requested the following: \n\"Actions to be taken by Customer/User\nPending correction by GE HealthCare, you can continue to use your device by following the instructions below.\n1. Determine the number of central stations that are connected to the network including those in any offsite Central Monitoring Unit.\n2. Ensure the number of connected central stations are fewer than 118 or more than 120.\nIf you need assistance completing steps 1 or 2, please contact GE HealthCare Service or your local Service Representative.\nNote: Any versions prior to CSCS V3.0.5 are not affected by this issue.\nEnsure all users are aware of, understand, and follow these instructions.\nPlease retain this document for your records. \nGE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. \nIf you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "173 units", "distribution_pattern": "Worldwide distribution.", "openfda": { "k_number": [ "K851496", "K103473", "K173107", "K822517", "K844650", "K934093", "K133882", "K850343", "K013515", "K001112", "K780782", "K810164", "K851400", "K831783", "K962811", "K851628", "K801000", "K840209", "K803123", "K201162", "K992636", "K212208", "K905788", "K113214", "K151736", "K053356", "K100272", "K161880", "K133994", "K132488", "K942685", "K170537", "K131816", "K873774", "K131272", "K151366", "K760523", "K832022", "K854372", "K172969", "K131919", "K830899", "K901884", "K926219", "K161767", "K890353", "K811911", "K173381", "K781256", "K212003", "K831781", "K883031", "K810168", "K180534", "K162012", "K770279", "K122167", "K932894", "K901072", "K780425", "K101474", "K170460", "K833819", "K760721", "K821491", "K926162", "K073372", "K111905", "K112645", "K884423", "K902334", "K883973", "K945277", "K110085", "K810165", "K831782", "K083321", "K932724" ], "registration_number": [ "2936999", "3016701404", "9610773", "8043933", "3005334138", "3007734888", "3010698831", "3013500228", "3018094310", "3012359877", "3016618143", "3029871637", "1218950", "9611109", "8043316", "1220908", "9610816", "3006615345", "3019269298", "3008729547", "3008483389", "3015181391", "3016851379", "3001570235", "3007540658", "2184149", "3002579136", "3010400367", "3011050570", "3013247477", "1220246", "3020704423", "1651104", "9613188", "3013596024", "3010331645", "3000126629", "3015328411" ], "fei_number": [ "2936999", "3016701404", "3005334138", "3007734888", "3010698831", "3002807798", "3013500228", "3018094310", "1000139754", "3012359877", "3002807167", "3016618143", "3029871637", "3002619595", "1218950", "1220908", "3006615345", "3003319165", "3008729547", "3019269298", "3008483389", "3015181391", "3016851379", "3001570235", "3007540658", "3002808267", "3004455125", "3002579136", "3010400367", "3011050570", "3013247477", "1220246", "3020704423", "3002737156", "3013596024", "3010331645", "3000126629", "3015328411" ], "device_name": "Display, Cathode-Ray Tube, Medical", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2450", "device_class": "2" } } ] }