Z-1708-2020Class II

Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version...

Name: Z-1708-2020 Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version...
Creator: Shanghai United Imaging Healthcare Co., Ltd.
Published: 2019-08-26
License: https://open.fda.gov/license/

Shanghai United Imaging Healthcare Co., Ltd. / initiated 2019-08-26 / Terminated / root cause: software

FDA source

Shanghai United Imaging Healthcare Co., Ltd. began a recall of 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... on 2019-08-26. FDA classified it as Class II and gives the reason as "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...". 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-1708-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-26
Posted: 2020-04-15
Terminated: 2022-05-18
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.
Product code: KPS System, Tomography, Computed, Emission
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.
Root cause tag: software
FDA 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 in commerce: 2 units
Distribution: US Nationwide distribution in the state TX.
Product codes and lots: Serial Numbers: 200017 and 200023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1708-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1708-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-15

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)