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

FDA device recall Z-0087-2023 · posted 2022-10-13 · Open, Classified

Recall details

Recalling firm

Shanghai United Imaging Healthcare Co., Ltd.

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.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

KPS

Quantity affected

32

Distribution

Distribution to US states of TX, WI, CA, and MI

Date initiated

2022-05-30

Date posted

2022-10-13

Location

Shanghai, China

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