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uEXPLORER PET/CT Diagnostic Imaging System - Product Usage:… recallZ-2799-2020 · Shanghai United Imaging Healthcare Co., Ltd. · initiated Jul 16, 2020

Terminated

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

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.

FDA root cause category: Device Design

What the company is doing

Urgent Medical Device Correction Letters regarding the uEXPLORER and uMI 550 were sent to customers on July 16, 2020 via email. Customers were informed that the firm had received complaints on these products and advised customers to take the following actions if problems were observed: 1. if image artifacts occur, reboot the system and continue the reconstruction. If necessary, repeat the scan which will result in an additional dose of radiation and the possible need for additional contrast medium. 2. If scout scanning is unexpectedly interrupted, try repeating the scout. This will result in an additional dose of radiation. 3: Be careful to avoid the sharp edge when the patient raises their arms during movement of the Ml patient table. Customers with questions may contact their United Imaging Service Engineer or call the United Imaging Customer Contact Center at 24-hour hotline (855) 221-1552 (toll free) or (832) 699-2799 (direct). Customers were advised to report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regulatory mail or by fax. Customers were requested to in-turn notify all users of the affected products via the Customer Notification Letter. Customers were informed that United Imaging is updating software to solve these issues, and that United Imaging will replace the mylar strip with an improved one on the affected products via on-site update. Customers are requested to sign the Receipt of Customer Notification Form indicating they received the notice and that they will extend the notification to the final customer. Signed forms are to be returned to the recalling firm.

Recall details

Recall number
Z-2799-2020
Status
Terminated
Initiated by the company
Jul 16, 2020
Posted by the FDA
Aug 13, 2020
Recalling firm
Shanghai United Imaging Healthcare Co., Ltd.
Quantity
1 unit distributed to Texas
Product code
KPS
FDA submissions
K182938
Distribution
US Nationwide distribution including in the state of Texas.

Product description

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 planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Code information (models, lots, serial numbers)

Serial No. F00002; GTIN 06971576832040

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 85948).

Sources and updates

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