Shanghai United Imaging Healthcare Co., Ltd.: uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the

Is my product affected?

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 no

• UPC 06971576832040

Check against the official notice below — it lists the full affected range.

What happened

Shanghai United Imaging Healthcare Co., Ltd. has recalled the uEXPLORER PET/CT Diagnostic Imaging System due to three potential issues: intermittent problems that may cause image data problems and artifacts, potential interruptions during scout scanning due to angle signal drift from external interference, and a metal edge overlap of a mylar strip in the gantry that may create a sharp edge. One unit with Serial No. F00002 was distributed to Texas as part of the nationwide U.S. distribution.

The potential consequences of these issues include repeat scanning procedures and abrasions to patients or operators. However, the source document does not specify what remedy affected consumers should pursue.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: US Nationwide distribution including in the state of Texas. Quantity: 1 unit distributed to Texas Lot/code info: Serial No. F00002; GTIN 06971576832040

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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