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uMI recallZ-0087-2023 · Shanghai United Imaging Healthcare Co., Ltd. · initiated May 30, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Shanghai United Imaging Healthcare Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0087-2023
Status
Open, Classified
Initiated by the company
May 30, 2022
Posted by the FDA
Oct 13, 2022
Recalling firm
Shanghai United Imaging Healthcare Co., Ltd.
Quantity
32
Product code
KPS
FDA submissions
K182237, K193241
Distribution
Distribution to US states of TX, WI, CA, and MI

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K182237, K193241 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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