{"recall":{"id":"fda-device-99536","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"GE Medical Systems Information Technologies Inc recalls 4 products","firm":"GE Medical Systems Information Technologies Inc","date":"2026-07-20","reported":"2026-09-02","status":"Ongoing","classification":"Class II","products":[{"name":"PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209","code":"GTIN 00195278679284, Serial Numbers: SWT25250001TA, SWT25360001TA, SWT25360002TA, SWT24090006TA, SWT25100001TA, SWT25120002TA, SWT24140007TA, SWT24150008TA, SWT25100004TA, SWT24050001TA, SWT25110003TA, SWT24180011TA, SWT25120003TA, SWT25230001TA, SWT25230002TA, SWT25110009TA, SWT25110010TA, SWT25230003TA, SWT25230005TA, SWT25230006TA, SWT25230004TA, SWT25260001TA, SWT31240012TA.","quantity":"23 units","number":"Z-3036-2026","classification":"Class II"},{"name":"PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592","code":"GTIN 00198953056752, Serial Numbers: SWT25510001TA, SWT26110010TA, SWT26070001TA, SWT26120008TA.","quantity":"4 units","number":"Z-3037-2026","classification":"Class II"},{"name":"PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353","code":"GTIN 00195278364838, Serial Numbers: SUC23080050TA, SUD22470001TA, SUD22420001TA, SUD22470010TA, SUD23390001TA, SUD23390003TA, SUD23390004TA, SUD23390009TA, SUD23390010TA, SUD22470009TA, SUD22470003TA, SUD22470004TA, SUD22470005TA, SUD23390005TA, SUD22280002TA.","quantity":"15 units","number":"Z-3038-2026","classification":"Class II"},{"name":"FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225","code":"UDI-DI (GTIN) 00195278679307","quantity":"0","number":"Z-3039-2026","classification":"Class II"}],"reason":"Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US:  MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.","nationwide":false,"states":["MI","NY"],"units":"23 units; 4 units; 15 units; 0","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99536","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"04ce821a88eb7c55","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99536","record":[{"status":"Ongoing","city":"Waukesha","state":"WI","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99536","recalling_firm":"GE Medical Systems Information Technologies Inc","address_1":"3114 N Grandview Blvd","address_2":"N/A","postal_code":"53188-1615","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US:  MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.","recall_number":"Z-3036-2026","product_description":"PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209","product_quantity":"23 units","reason_for_recall":"Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.","recall_initiation_date":"20260720","center_classification_date":"20260827","report_date":"20260902","code_info":"GTIN 00195278679284, Serial Numbers:  SWT25250001TA, SWT25360001TA, SWT25360002TA, SWT24090006TA, SWT25100001TA, SWT25120002TA, SWT24140007TA, SWT24150008TA, SWT25100004TA, SWT24050001TA, SWT25110003TA, SWT24180011TA, SWT25120003TA, SWT25230001TA, SWT25230002TA, SWT25110009TA, SWT25110010TA, SWT25230003TA, SWT25230005TA, SWT25230006TA, SWT25230004TA, SWT25260001TA, SWT31240012TA."},{"status":"Ongoing","city":"Waukesha","state":"WI","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99536","recalling_firm":"GE Medical Systems Information Technologies Inc","address_1":"3114 N Grandview Blvd","address_2":"N/A","postal_code":"53188-1615","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US:  MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.","recall_number":"Z-3037-2026","product_description":"PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592","product_quantity":"4 units","reason_for_recall":"Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.","recall_initiation_date":"20260720","center_classification_date":"20260827","report_date":"20260902","code_info":"GTIN 00198953056752, Serial Numbers:  SWT25510001TA, SWT26110010TA, SWT26070001TA, SWT26120008TA."},{"status":"Ongoing","city":"Waukesha","state":"WI","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99536","recalling_firm":"GE Medical Systems Information Technologies Inc","address_1":"3114 N Grandview Blvd","address_2":"N/A","postal_code":"53188-1615","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US:  MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.","recall_number":"Z-3038-2026","product_description":"PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353","product_quantity":"15 units","reason_for_recall":"Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.","recall_initiation_date":"20260720","center_classification_date":"20260827","report_date":"20260902","code_info":"GTIN 00195278364838, Serial Numbers:  SUC23080050TA, SUD22470001TA, SUD22420001TA, SUD22470010TA, SUD23390001TA, SUD23390003TA, SUD23390004TA, SUD23390009TA, SUD23390010TA, SUD22470009TA, SUD22470003TA, SUD22470004TA, SUD22470005TA, SUD23390005TA, SUD22280002TA."},{"status":"Ongoing","city":"Waukesha","state":"WI","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99536","recalling_firm":"GE Medical Systems Information Technologies Inc","address_1":"3114 N Grandview Blvd","address_2":"N/A","postal_code":"53188-1615","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US:  MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.","recall_number":"Z-3039-2026","product_description":"FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225","product_quantity":"0","reason_for_recall":"Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.","recall_initiation_date":"20260720","center_classification_date":"20260827","report_date":"20260902","code_info":"UDI-DI (GTIN) 00195278679307"}]}}