uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthca

FDA device recall Z-2799-2020 · posted 2020-08-13 · Terminated

Recall details

Recalling firm

Shanghai United Imaging Healthcare Co., Ltd.

Reason for recall

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

KPS

Quantity affected

1 unit distributed to Texas

Distribution

US Nationwide distribution including in the state of Texas.

Date initiated

2020-07-16

Date posted

2020-08-13

Date terminated

2022-07-07

Location

Shanghai, China

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