{"recall":{"id":"fda-device-99731","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Shanghai United Imaging Healthcare Co., Ltd. recalls 12 products","firm":"Shanghai United Imaging Healthcare Co., Ltd.","date":"2026-08-11","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"Computed Tomography X-ray System, Model: uCT 530 with software","code":"UDI-DI: 06971576831012. Serial Numbers/Software: 300174/R001.19.5.1839204-Re3300SP1H1_P4, 304006/R001.17.6.1607336-Re3100SP4, 304007/R001.19.4.1810621-Re3300SP1H1_P3, 304008/R001.19.4.1810621-Re3300SP1H1_P3","quantity":"4","number":"Z-3277-2026","classification":"Class II"},{"name":"Computed Tomography X-ray System, Model: uCT 550 with software","code":"UDI-DI: 06971576831036. Serial Numbers/Software: 353021/R001.19.6.1857994-Re3300SP1H1_P5, 353045/R001.19.6.1857994-Re3300SP1H1_P5, 353049/R001.19.6.1857994-Re3300SP1H1_P5, 354001/R001.19.6.1857994-Re3300SP1H1_P5, 354004/R001.19.6.1857994-Re3300SP1H1_P5, 354005/R001.19.6.1857994-Re3300SP1H1_P5, 354007/R001.19.6.1857994-Re3300SP1H1_P5, 354009/R001.19.6.1857994-Re3300SP1H1_P5, 354013/R001.19.6.1857994-Re3300SP1H1_P5, 354015/R001.19.6.1857994-Re3300SP1H1_P5, 354016/R001.19.6.1857994-Re3300SP1H1_P5, 354018/R001.17.6.1607336-Re3100SP4, 354020/R001.17.6.1607336-Re3100SP4, 354021/R001.17.6.1607336-Re3100SP4, 354022/R001.19.4.1810621-Re3300SP1H1_P3, 354023/R001.19.6.1857994-Re3300SP1H1_P5, 354024/R001.19.6.1857994-Re3300SP1H1_P5, 354025/R001.19.6.1857994-Re3300SP1H1_P5, 354026/R001.19.6.1857994-Re3300SP1H1_P5, 354027/R001.19.6.1857994-Re3300SP1H1_P5, 354028/R001.19.6.1857994-Re3300SP1H1_P5, 354029/R001.19.6.1857994-Re3300SP1H1_P5, 354030/R001.19.6.1857994-Re3300SP1H1_P5","quantity":"23","number":"Z-3278-2026","classification":"Class II"},{"name":"Computed Tomography X-ray System, Model: uCT 760 with software","code":"UDI-DI: 06971576831043. Serial Number/Software: 600271/R003.8.4.1810621-Re3300SP1H1_P3","quantity":"1","number":"Z-3279-2026","classification":"Class II"},{"name":"Computed Tomography X-ray System, Model: uCT 780 with software","code":"UDI-DI: 06971576831050. Serial Number/Software: 684001/R001.17.6.1607336-Re3100SP4, 684002/R001.17.6.1607336-Re3100SP4, 684003/R003.8.4.1810621-Re3300SP1H1_P3, 684004/R003.8.4.1810621-Re3300SP1H1_P3, 684005/R003.8.4.1810621-Re3300SP1H1_P3, 684006/R003.8.4.1810621-Re3300SP1H1_P3, 684007/R003.8.4.1810621-Re3300SP1H1_P3, 684008/R003.8.4.1810621-Re3300SP1H1_P3, 684009/R003.8.4.1810621-Re3300SP1H1_P3, 684010/R003.8.4.1810621-Re3300SP1H1_P3, 684011/R003.8.4.1810621-Re3300SP1H1_P3, 684012/R003.9.0.1776134-Re-3300SP2, 684013/R003.11.0.1897081-Re3310SP1, 684014/R003.11.0.1897081-Re3310SP1","quantity":"14","number":"Z-3280-2026","classification":"Class II"},{"name":"Computed Tomography X-ray System, Model: uCT ATLAS with software","code":"UDI-DI: 06971576831104. Serial Number/Software: 863001/R001.17.6.1607336-Re3100SP4, 863002/R001.17.6.1607336-Re3100SP4, 863004/R001.17.6.1607336-Re3100SP4, 863005/R001.17.6.1607336-Re3100SP4, 863007/R001.21.0.1897081-Re3310SP1, 863008/R001.21.0.1897081-Re3310SP1, 869001/R001.22.0.2012850-Re3320, 869002/R001.19.4.1810621-Re3300SP1H1_P3, 869003/R001.21.0.1897081-Re3310SP1, 869004/R001.21.0.1897081-Re3310SP1, 11CT863010/R001.17.6.1607336-Re3100SP4","quantity":"11","number":"Z-3281-2026","classification":"Class II"},{"name":"Computed Tomography X-ray System, Model: uCT ATLAS Astound with software","code":"UDI-DI: 06971576831340. Serial Number/Software: 803011/R002.9.0.1897081-Re3310SP1, 803012/R002.4.6.1607336-Re3100SP4, 803013/R002.4.6.1607336-Re3100SP4, 803014/R002.9.0.1897081-Re3310SP1, 803016/R002.4.6.1607336-Re3100SP4, 803017/R002.9.0.1897081-Re3310SP1, 803018/R002.9.0.1897081-Re3310SP1, 803019/R002.4.6.1607336-Re3100SP4, 803020/R002.9.0.1897081-Re3310SP1, 803022/R002.9.0.1897081-Re3310SP1, 803023/R002.9.0.1897081-Re3310SP1, 803024/R002.9.0.1897081-Re3310SP1, 809001/R002.8.1.1840891-Re3310A_P1, 809002/R002.9.0.1897081-Re3310SP1, 809003/R002.8.1.1840891-Re3310A_P1, 809004/R002.4.6.1607336-Re3100SP4, 809005/R002.4.6.1607336-Re3100SP4, 809006/R002.8.1.1840891-Re3310A_P1, 809007/R002.4.7.1671762-Re3100SP4_P1, 809008/R002.4.7.1671762-Re3100SP4_P1, 809009/R002.4.7.1671762-Re3100SP4_P1, 809010/R002.4.7.1671762-Re3100SP4_P1, 809011/R002.4.7.1671762-Re3100SP4_P1, 809012/R002.4.7.1671762-Re3100SP4_P1, 809013/R002.4.7.1671762-Re3100SP4_P1, 809014/R002.7.4.1810621-Re3300SP1H1_P3, 809015/R002.7.4.1810621-Re3300SP1H1_P3, 809016/R002.9.0.1897081-Re3310SP1, 809017/R002.9.0.1897081-Re3310SP1, 809018/R002.7.4.1810621-Re3300SP1H1_P3, 809019/R002.7.4.1810621-Re3300SP1H1_P3, 809020/R002.9.0.1897081-Re3310SP1, 809021/R002.7.4.1810621-Re3300SP1H1_P3, 809022/R002.7.4.1810621-Re3300SP1H1_P3, 809023/R002.7.4.1810621-Re3300SP1H1_P3, 809024/R002.7.4.1810621-Re3300SP1H1_P3, 809025/R002.7.4.1810621-Re3300SP1H1_P3, 809026/R002.7.4.1810621-Re3300SP1H1_P3, 809027/R002.7.4.1810621-Re3300SP1H1_P3, 809028/R002.9.0.1897081-Re3310SP1, 809029/R002.7.4.1810621-Re3300SP1H1_P3, 809030/R002.7.4.1810621-Re3300SP1H1_P3, 809031/R002.7.4.1810621-Re3300SP1H1_P3, 809032/R002.7.4.1810621-Re3300SP1H1_P3, 809033/R002.9.0.1897081-Re3310SP1, 809034/R002.9.0.1897081-Re3310SP1, 809035/R002.9.0.1897081-Re3310SP1, 809036/R002.9.0.1897081-Re3310SP1, 809037/R002.9.0.1897081-Re3310SP1, 809038/R002.9.0.1897081-Re3310SP1, 809039/R002.9.0.1897081-Re3310SP1, 809040/R002.9.0.1897081-Re3310SP1, 809041/R002.9.0.1897081-Re3310SP1","quantity":"53","number":"Z-3282-2026","classification":"Class II"},{"name":"Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software","code":"UDI-DI: 06971576832026. Serial Number/Software: 200045/R001.19.0.1812568, 200163/R001.19.3.2011750, 200164/R001.18.0.1683822, 200165/R001.18.0.1683822, 200166/R001.18.0.1683822, 200167/R001.18.0.1683822, 202009/R001.19.3.2011750, 202016/R001.19.0.1812568, 202018/R001.19.0.1812568, 202019/R001.19.0.1812568, 202020/R001.19.1.1929746, 202021/R001.19.1.1929746, 202022/R001.19.1.1929746, 230040/R001.19.3.2011750, 230048/R001.19.0.1812568, 230106/R001.19.0.1812568, 232038/R001.19.0.1812568, 232039/R001.19.0.1812568, 232040/R001.19.0.1812568, 232041/R001.19.0.1812568, 232042/R001.19.0.1812568, 232043/R001.19.0.1812568, 232044/R001.19.0.1812568, 232045/R001.19.0.1812568, 232046/R001.19.0.1812568, 232047/R001.19.0.1812568, 232048/R001.19.1.1929746, 232049/R001.19.1.1929746, 232050/R001.19.1.1929746, 232051/R001.19.1.1929746, 202023/R001.19.1.1929746, 202024/R001.19.1.1929746, 232052/R001.19.1.1929746, 232053/R001.19.1.1929746","quantity":"34","number":"Z-3283-2026","classification":"Class II"},{"name":"Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software","code":"UDI-DI: 06971576832170. Serial Number: 11MI410003/R001.19.4.1909524, 11MI410004/R001.19.4.1909524, 11MI410005/R001.19.4.1909524, 20MI410001/R001.19.4.1909524, 20MI410002/R001.19.4.1909524, 20MI410003/R001.21.0.1993334, 20MI410004/R001.19.4.1909524","quantity":"7","number":"Z-3284-2026","classification":"Class II"},{"name":"Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software","code":"UDI-DI: 06971576832187. Serial Number: 11MIP00007/R001.17.5.1785268, 11MIP00009/R001.18.2.1967222, 11MIP00010/R001.18.2.1967222","quantity":"3","number":"Z-3285-2026","classification":"Class II"},{"name":"Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software","code":"UDI-DI: 06971576832231. Serial Number/Software: 11MI500004/R002.4.0.1872339, 11MI500005/R002.4.0.1872339, 11MI500006/R002.4.0.1872339","quantity":"3","number":"Z-3286-2026","classification":"Class II"},{"name":"Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software","code":"UDI-DI: 06971576832255. Serial Number/Software: 11MI510005/R003.2.0.1872339, 20MI510001/R003.2.0.1872339, 20MI510002/R003.2.0.1872339, 20MI510003/R003.2.0.1872339, 20MI510004/R003.2.0.1872339, 20MI510005/R003.2.0.1872339","quantity":"6","number":"Z-3287-2026","classification":"Class II"},{"name":"Positron Emission Tomography and Computed Tomography System, Model: uMI 780","code":"UDI-DI: 06971576832033. Serial Number/Software: 300098/R001. 19.0.1812568","quantity":"1","number":"Z-3288-2026","classification":"Class II"}],"reason":"Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.","nationwide":true,"states":[],"units":"4; 23; 1; 14; 11; 53; 34; 7; 3; 3; 6; 1","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=99731","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"677608c8043cd31d","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=99731","record":[{"status":"Ongoing","city":"Shanghai","state":"","country":"China","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99731","recalling_firm":"Shanghai United Imaging Healthcare Co., Ltd.","address_1":"No. 2258 Chengbei Rd, Jiading Ind.","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.","recall_number":"Z-3277-2026","product_description":"Computed Tomography X-ray System, Model: uCT 530 with software","product_quantity":"4","reason_for_recall":"Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.","recall_initiation_date":"20260811","center_classification_date":"20260925","report_date":"20261007","code_info":"UDI-DI: 06971576831012.  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Serial Numbers/Software:  353021/R001.19.6.1857994-Re3300SP1H1_P5,  353045/R001.19.6.1857994-Re3300SP1H1_P5,  353049/R001.19.6.1857994-Re3300SP1H1_P5,  354001/R001.19.6.1857994-Re3300SP1H1_P5,  354004/R001.19.6.1857994-Re3300SP1H1_P5,  354005/R001.19.6.1857994-Re3300SP1H1_P5,  354007/R001.19.6.1857994-Re3300SP1H1_P5,  354009/R001.19.6.1857994-Re3300SP1H1_P5,  354013/R001.19.6.1857994-Re3300SP1H1_P5,  354015/R001.19.6.1857994-Re3300SP1H1_P5,  354016/R001.19.6.1857994-Re3300SP1H1_P5,  354018/R001.17.6.1607336-Re3100SP4,  354020/R001.17.6.1607336-Re3100SP4,  354021/R001.17.6.1607336-Re3100SP4,  354022/R001.19.4.1810621-Re3300SP1H1_P3,  354023/R001.19.6.1857994-Re3300SP1H1_P5,  354024/R001.19.6.1857994-Re3300SP1H1_P5,  354025/R001.19.6.1857994-Re3300SP1H1_P5,  354026/R001.19.6.1857994-Re3300SP1H1_P5, 354027/R001.19.6.1857994-Re3300SP1H1_P5,  354028/R001.19.6.1857994-Re3300SP1H1_P5,  354029/R001.19.6.1857994-Re3300SP1H1_P5, 354030/R001.19.6.1857994-Re3300SP1H1_P5","more_code_info":""},{"status":"Ongoing","city":"Shanghai","state":"","country":"China","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99731","recalling_firm":"Shanghai United Imaging Healthcare Co., Ltd.","address_1":"No. 2258 Chengbei Rd, Jiading Ind.","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.","recall_number":"Z-3279-2026","product_description":"Computed Tomography X-ray System, Model: uCT 760 with software","product_quantity":"1","reason_for_recall":"Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.","recall_initiation_date":"20260811","center_classification_date":"20260925","report_date":"20261007","code_info":"UDI-DI: 06971576831043. Serial Number/Software: 600271/R003.8.4.1810621-Re3300SP1H1_P3","more_code_info":""},{"status":"Ongoing","city":"Shanghai","state":"","country":"China","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99731","recalling_firm":"Shanghai United Imaging Healthcare Co., Ltd.","address_1":"No. 2258 Chengbei Rd, Jiading Ind.","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.","recall_number":"Z-3280-2026","product_description":"Computed Tomography X-ray System, Model: uCT 780 with software","product_quantity":"14","reason_for_recall":"Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.","recall_initiation_date":"20260811","center_classification_date":"20260925","report_date":"20261007","code_info":"UDI-DI: 06971576831050.  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