- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- 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.
- Affected products (lot / model / serial)
- 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
- Units affected
- 53
- 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.
- Firm location
- Shanghai, China
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3282-2026
- Recall initiated
- August 11, 2026
- FDA classification date
- September 25, 2026
- FDA report date
- October 7, 2026
- FDA event ID
- 99731
- Last updated on HTM Vibe
- October 13, 2026
