FDA Medical Device Recalls (openFDA)
Shanghai United Imaging Healthcare Co., Ltd.: 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 number
- Z-1708-2020
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2019-08-26
- Posted
- not on file
- Terminated
- 2022-05-18
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the state TX.
- Lot, serial or model codes
- Serial Numbers: 200017 and 200023
- 510(k) numbers
- ["K182237"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 3011015597
- Firm city
- Shanghai
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28