Z-2819-2020Class II

Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 -

Name: Z-2819-2020 Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 -
Creator: Shanghai United Imaging Healthcare Co., Ltd.
Published: 2020-03-26
License: https://open.fda.gov/license/

Shanghai United Imaging Healthcare Co., Ltd. / initiated 2020-03-26 / Terminated / root cause: software

FDA source

Shanghai United Imaging Healthcare Co., Ltd. began a recall of Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated... on 2020-03-26. FDA classified it as Class II and gives the reason as "In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2819-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-26
Posted: 2020-08-18
Terminated: 2023-08-02
Recalling firm: Shanghai United Imaging Healthcare Co., Ltd.
Product: Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - 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.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan.
Root cause tag: software
FDA root cause: Software design
Action: On March 26, 2020, Customer Notification Letters were emailed to customers. The recalling firm has released a software hotfix to address the issue for the affected products. The corrective action of on-site upgrade will be provided free of charge. For further questions, feel free to contact the Customer Contact Center at (855) 221-1552 (toll free) or (832) 699-2799 (direct).
Quantity in commerce: 3
Distribution: US Nationwide distribution including in the state of TX.
Product codes and lots: UDI: 06971576832026, Software Version: R001.3.0.0.750505, Serial Numbers: 200017, 200023, 200024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2819-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2819-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-26	2020-08-18

Product code KPS

K182237Class IIuMI 550 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd. / cleared 2018-10-12

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)