Z-0087-2023Class II

Positron Emission Tomography and Computed Tomography System, Model: uMI 550

Name: Z-0087-2023 Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Creator: Shanghai United Imaging Healthcare Co., Ltd.
Published: 2022-05-30
License: https://open.fda.gov/license/

Shanghai United Imaging Healthcare Co., Ltd. / initiated 2022-05-30 / Open, Classified / root cause: design

FDA source

Shanghai United Imaging Healthcare Co., Ltd. began a recall of Positron Emission Tomography and Computed Tomography System, Model: uMI 550 on 2022-05-30. FDA classified it as Class II and gives the reason as "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...". 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-0087-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-30
Posted: 2022-10-13
Recalling firm: Shanghai United Imaging Healthcare Co., Ltd.
Product: Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: On 5/30/22, advisory notices were emailed to customers who were asked to do the following: If the connection is not stable, perform a system reboot immediately and observe if the ECG and respiratory signals are restored. 2. If a system reboot cannot restore the wireless connection, use a third-party trigger device that supports 50ohm BNC interface and TTL output pulse with 100ms width, and connect to the system's external trigger port on the front cover. The port can be located according to Section 3.4.7 of the System Operator Manual. a) Make sure ECG and respiratory square pulse signals are displayed on the console monitor; b) Perform gated reconstruction based on the ECG and respiratory trigger pulses. 3. For further questions, please contact your recalling firm service engineer or call the Customer Contact Center's 24-hour hotline at (855) 221-1552 (toll-free) or (832) 699-2799 (direct). 4. Notify all your internal users of the PET/CT system, using this letter. 5. Complete and return the Receipt of Advisory Notification. The recalling firm will perform a design change and update the firmware of the wireless VSM module to resolve this issue. This design change is scheduled to be released for the on-site upgrade in August 2022.
Quantity in commerce: 32
Distribution: Distribution to US states of TX, WI, CA, and MI
Product codes and lots: UDI-DI/Serial Numbers: 06971576832026/230002, 230003, 230004, 230005, 230006, 230007, 230008, 230009, 230010, 230011, 230012, 230013, 230014, 230015, 230016, 230017, 230019, 230020, 230021, 230022, 230023, 230024, 230025, 230026, 230027, 230028, 230029, 230030, 230031, 230032, 230033, 232001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0087-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0087-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-13

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)