Z-2593-2021Class II

uMI 550 System -

Name: Z-2593-2021 uMI 550 System -
Creator: Shanghai United Imaging Healthcare Co., Ltd.
Published: 2021-08-02
License: https://open.fda.gov/license/

Shanghai United Imaging Healthcare Co., Ltd. / initiated 2021-08-02 / Open, Classified / root cause: design

FDA source

Shanghai United Imaging Healthcare Co., Ltd. began a recall of uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging... on 2021-08-02. FDA classified it as Class II and gives the reason as "The EXAM acquisition workflow could occasionally freeze after canceling the PET scan". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2593-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-08-02
Posted: 2021-09-29
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.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Root cause tag: design
FDA 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 in commerce: 23 systems
Distribution: U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2593-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2593-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-10-06	2021-09-29
Z-2594-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-10-06	2021-09-29

Product code KPS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)