Shanghai, China
Shanghai United Imaging Healthcare Co., Ltd. recalls
15 recalls recorded since 2018, most recently on 11 August 2026. 8 are listed as ongoing. Status and classification are as published by the FDA.
Recalls15
Ongoing (FDA)8
Terminated or completed7
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 11 August 2026
- Reason
- Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
- Distribution
- US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3277-2026, Z-3278-2026, Z-3284-2026, Z-3287-2026, Z-3280-2026, Z-3281-2026, Z-3282-2026, Z-3286-2026, Z-3285-2026, Z-3279-2026, Z-3283-2026, Z-3288-2026
- Computed Tomography X-ray System, Model: uCT 530 with software
- Computed Tomography X-ray System, Model: uCT 550 with software
- Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
- Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
- Computed Tomography X-ray System, Model: uCT 780 with software
- Computed Tomography X-ray System, Model: uCT ATLAS with software
- Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
- Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software
- and 4 more product lines
Ongoing Class II Medical devices
- Recall started
- 1 March 2023
- Reason
- Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images.
- Distribution
- U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1353-2023
- Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
Ongoing Class II Medical devices
- Recall started
- 30 May 2022
- Reason
- The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition can result in the failure of ECG and respiratory-gated reconstruction of the PET scan, which may require rescanning of the patient.
- Distribution
- Distribution to US states of TX, WI, CA, and MI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0087-2023
- Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Ongoing Class II Medical devices
- Recall started
- 2 August 2021
- Reason
- The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
- Distribution
- U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2594-2021, Z-2593-2021
- uEXPLORER PET/CT 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 ev
- 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
Terminated Class II Medical devices
- Recall started
- 25 January 2021
- Terminated
- 3 May 2022
- Reason
- There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.
- Distribution
- US Nationwide distribution in the state of TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1160-2021
- Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking d
Ongoing Class II Medical devices
- Recall started
- 5 August 2020
- Reason
- A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
- Distribution
- US Nationwide distribution including in the state of TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0448-2021, Z-0447-2021, Z-0446-2021, Z-0445-2021
- Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localiz
- Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at differe
- Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at differe
- Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at differe
Terminated Class II Medical devices
- Recall started
- 16 July 2020
- Terminated
- 7 July 2022
- Reason
- 1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions.
- Distribution
- US Nationwide distribution including in the state of Texas.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2799-2020, Z-2800-2020
- uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment
- uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment pl
Ongoing Class II Medical devices
- Recall started
- 20 June 2020
- Reason
- The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
- Distribution
- US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2704-2020, Z-2703-2020, Z-2705-2020
- Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken
- Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken
- Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken
Ongoing Class II Medical devices
- Recall started
- 23 May 2020
- Reason
- Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.
- Distribution
- US Distribution to state of: TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2641-2020
- Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional i
Terminated Class II Medical devices
- Recall started
- 8 May 2020
- Terminated
- 20 January 2022
- Reason
- Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This may result in the need for rescanning of the patient with the patient receiving an additional dose of radiation and possible use of additional contrast media.
- Distribution
- Distributed to two customers. Both customers located in Houston, Texas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2522-2020
- uCT 760 System, Computed Tomography X-ray System
Ongoing Class II Medical devices
- Recall started
- 8 May 2020
- Reason
- Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.
- Distribution
- Distributed to Texas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2472-2020
- uCT 530 Computed Tomography X-Ray System
Terminated Class II Medical devices
- Recall started
- 26 March 2020
- Terminated
- 2 August 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution including in the state of TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2819-2020
- 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 detect
Terminated Class II Medical devices
- Recall started
- 27 February 2020
- Terminated
- 28 May 2021
- Reason
- Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the image is acquired with the wrong reference position, clinical diagnostic requirements cannot be met.T2. Where image stitching is used, the left and right tag information may be lost. When these problems are encountered, an additional exposure is needed and the patient will receive more radiation.
- Distribution
- US Nationwide distribution including in the state of Texas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2521-2020
- uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull,
Terminated Class II Medical devices
- Recall started
- 26 August 2019
- Terminated
- 18 May 2022
- 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.
- Distribution
- US Nationwide distribution in the state TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1708-2020
- 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 q
Terminated Class II Medical devices
- Recall started
- 30 July 2019
- Terminated
- 17 May 2022
- Reason
- X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.
- Distribution
- US Nationwide distribution in the state of TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1075-2022
- Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.