Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Brand
Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China
Lot Codes / Batch Numbers
Serial Numbers: 200017 and 200023
Products Sold
Serial Numbers: 200017 and 200023
Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China is recalling Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R0 due to Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction pro. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.
Recommended Action
Per FDA guidance
On August 26, 2019, the firm emailed consignee an "Customer Notification" recall letter. In addition to informing consignees about the recall letter, the notification ask consignees to take the following actions: 1. If the user finds that PET reconstruction failing, the PET should be rescanned immediately to complete a new reconstruction. 2. If this occurs, please contact the UIH Solutions (UIHS) customer Contact Center at telephone numbers (855) 221-1552 (toll free) or (832) 699-2799 (direct) to report the issue.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026