United Imaging Recalls uEXPLORER PET/CT System for Potential Sharp Edges
Shanghai United Imaging Healthcare is recalling one uEXPLORER PET/CT Diagnostic Imaging System in Texas due to potential sharp edges and image data issues.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential sharp edges causing abrasions) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling one unit of the uEXPLORER PET/CT Diagnostic Imaging System. The recall is limited to a single unit distributed to Texas, identified by Serial No. F00002 and GTIN 06971576832040.
The recall was initiated due to three potential issues: intermittent problems that may cause image data artifacts, intermittent scout scanning interruptions caused by angle signal drift from external interference, and metal edge overlap of a mylar strip in the gantry that may create a sharp edge. These defects may lead to repeat scanning and abrasions.
The 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 oncology, cardiology, and neurology. Healthcare facilities that possess this specific unit should contact the manufacturer for instructions on how to address the recall.
The recalled product
- Product
- 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…
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Serial No. F00002
- GTIN 06971576832040
Distribution
Part of a larger recall action
This product is one of 2 recalled by Shanghai United Imaging Healthcare Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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