OVERLOOKED

Recalls › Medicines & devices

Class IIOngoing

Shanghai United Imaging Healthcare Co., Ltd. recalls 12 products

Recall date · record updated Oct 7, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

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.

Company
Shanghai United Imaging Healthcare Co., Ltd.
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).
Who’s 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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99731…

Products (12)

  1. Computed Tomography X-ray System, Model: uCT 530 with software

    Codes/lots: 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_P3Quantity: 4Recall no. Z-3277-2026Class II

  2. Computed Tomography X-ray System, Model: uCT 550 with software

    Codes/lots: 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-Re3Quantity: 23Recall no. Z-3278-2026Class II

  3. Computed Tomography X-ray System, Model: uCT 760 with software

    Codes/lots: UDI-DI: 06971576831043. Serial Number/Software: 600271/R003.8.4.1810621-Re3300SP1H1_P3Quantity: 1Recall no. Z-3279-2026Class II

  4. Computed Tomography X-ray System, Model: uCT 780 with software

    Codes/lots: 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-Re3310SP1Quantity: 14Recall no. Z-3280-2026Class II

  5. Computed Tomography X-ray System, Model: uCT ATLAS with software

    Codes/lots: 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-Re3100SP4Quantity: 11Recall no. Z-3281-2026Class II

  6. Computed Tomography X-ray System, Model: uCT ATLAS Astound with software

    Codes/lots: 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-RQuantity: 53Recall no. Z-3282-2026Class II

  7. Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software

    Codes/lots: 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, 232043Quantity: 34Recall no. Z-3283-2026Class II

  8. Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software

    Codes/lots: 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/R001.19.4.1909524Quantity: 7Recall no. Z-3284-2026Class II

  9. Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software

    Codes/lots: UDI-DI: 06971576832187. Serial Number: 11MIP00007/R001.17.5.1785268, 11MIP00009/R001.18.2.1967222, 11MIP00010/R001.18.2.1967222Quantity: 3Recall no. Z-3285-2026Class II

  10. Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software

    Codes/lots: UDI-DI: 06971576832231. Serial Number/Software: 11MI500004/R002.4.0.1872339, 11MI500005/R002.4.0.1872339, 11MI500006/R002.4.0.1872339Quantity: 3Recall no. Z-3286-2026Class II

  11. Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software

    Codes/lots: 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/R003.2.0.1872339Quantity: 6Recall no. Z-3287-2026Class II

  12. Positron Emission Tomography and Computed Tomography System, Model: uMI 780

    Codes/lots: UDI-DI: 06971576832033. Serial Number/Software: 300098/R001. 19.0.1812568Quantity: 1Recall no. Z-3288-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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