FDA Medical Device Recalls (openFDA)
Shanghai United Imaging Healthcare Co., Ltd.: uMI 550 System - Product Usage: 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-2593-2021
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Product
- uMI 550 System - Product Usage: 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
- Open, Classified
- Initiated
- 2021-08-02
- Posted
- not on file
- Terminated
- not on file
- Reason
- The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
- Root cause
- Device Design
- Action
- On 08/02/2021, the Firm emailed to its customer an "Advisory Notification" informing them of a potential safety-relevant issue in which the EXAM acquisition workflow could occasionally freeze after canceling the PET scan. The issue and the sequence of events leading to this occurrence are as follow: During a myocardial perfusion scan procedure, the follow steps could lead to the EXAM acquisition workflow to occasionally freeze- 1. Selecting the myocardial perfusion scan procedure and entering EXAM. 2. Finishing the CT scout and helical/cine scan. 3. Starting the PET scan. 4. Canceling the current PET scan -- in this case the EXAM acquisition workflow may shut down, resulting in an error message stating: "EXAM (Study ID: XXXXXXX) has some errors, trying to restart. Please wait and try again. 5. Reentering the EXAM acquisition workflow without restarting the system, and then attempting to continue the scan. If the above occurs, this may require rescanning of the patient, resulting in additional CT dose exposure. Customer are instructed to: 1. When the EXAM acquisition workflow is interrupted after cancellation of the scan, follow the steps to resume the procedure: a) Wait until CT reconstruction finishes. b) Perform a system restart. c) After restart, select the suspended procedure on the patient administration (PA) interface and enter EXAM. System will load and recover the status of this procedure. d) Duplicate or copy and paste the unfinished PET scan, and then continue. 2. Please notify all internal users of the PET/CT system, using this letter. 3. Complete and sign the Receipt of Advisory Notification Form and return it to the Recalling Firm via fax, email or mail. The Recalling Firm is working on releasing a software update to resolve this issue. Planned release of software update is Q4 of 2021. For questions, contact the Recalling Firm's service engineer or call the customer contact center's 24 hour hotline at (855)221-1552 (toll free) or (832)699-2799 (d
- Quantity
- 23 systems
- Distribution
- U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
- Lot, serial or model codes
- Model: 88000057 GTIN/UDI Codes: 06971576832026 / 01 06971576832026 240 88000057 21 200017 06971576832026 / 01 06971576832026 240 88000057 21 200023 06971576832026 / 01 06971576832026 240 88000057 21 200024 06971576832026 / 01 06971576832026 240 88000057 21 200036 06971576832026 / 01 06971576832026 240 88000057 21 200045 06971576832026 / 01 06971576832026 240 88000057 21 200047 06971576832057 / 01 06971576832057 240 88000057 21 230002 06971576832057 / 01 06971576832057 240 88000057 21 230003 06971576832057 / 01 06971576832057 240 88000057 21 230004 06971576832057 / 01 06971576832057 240 88000057 21 200059 06971576832057 / 01 06971576832057 240 88000057 21 230005 06971576832057 / 01 06971576832057 240 88000057 21 230006 06971576832057 / 01 06971576832057 240 88000057 21 230007 06971576832057 / 01 06971576832057 240 88000057 21 230008 06971576832057 / 01 06971576832057 240 88000057 21 230009 06971576832057 / 01 06971576832057 240 88000057 21 230010 06971576832057 / 01 06971576832057 240 88000057 21 230011 06971576832057 / 01 06971576832057 240 88000057 21 230012 06971576832057 / 01 06971576832057 240 88000057 21 230013 06971576832057 / 01 06971576832057 240 88000057 21 230014 06971576832057 / 01 06971576832057 240 88000057 21 230015 06971576832057 / 01 06971576832057 240 88000057 21 230016 06971576832057 / 01 06971576832057 240 88000057 21 230017 Serial Numbers: 200017; 200023; 200024; 200036; 200045; 200047; 230002; 230003; 230004; 200059; 230005; 230006; 230007; 230008; 230009; 230010; 230011; 230012; 230013; 230014; 230015; 230016; 230017;
- 510(k) numbers
- ["K182237","K193241"]
- 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