Device recall

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

FDA recall source

Recall number

Z-3282-2026

Event id

99731

Status

Ongoing

FDA classification

Class II

Recalling firm

Shanghai United Imaging Healthcare Co., Ltd.

Report date

Oct 7, 2026

Posted

Sep 25, 2026

Initiated

Aug 11, 2026

Center classification date

Sep 25, 2026

Product code

JAK

Device type

System, X-Ray, Tomography, Computed

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.

Root cause

Software design

Quantity

53

Code info

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

Distribution

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.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K203448K231482K243617

Location

Shanghai, China