FDA recall Z-1353-2023

Product

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057

Reason for recall

Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images.

Distribution

U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.

Key facts

Status

Ongoing

Initiation date

2023-03-01

Report date

2023-04-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Shanghai, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1353-2023