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.
- Company
- Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China
- Recall Initiated
- August 26, 2019
- Terminated
- May 18, 2022
- Recall Number
- Z-1708-2020
- Quantity
- 2 units
Reason for Recall
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.
Distribution
US Nationwide distribution in the state TX.
Lot / Code Info
Serial Numbers: 200017 and 200023
Root Cause
Software design
Action Taken
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.