United Imaging Recalls uMI 550 PET/CT Systems Due to Imaging and Safety Defects
Shanghai United Imaging Healthcare is recalling four uMI 550 PET/CT systems due to defects that may cause image artifacts, scanning interruptions, or sharp edges.
What this means for you
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 high-risk medical device with defects that may lead to physical injury (abrasions) and diagnostic errors, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling four units of the uMI 550 PET/CT Diagnostic Imaging System. The recall covers serial numbers 200017, 200023, 200024, and 200036. These systems were distributed nationwide in the United States, including in Texas.
The recall is due to three potential defects: a service function problem that may cause false marking of a bad channel resulting in ring artifacts; potential intermittent scout scanning interruption due to angle signal drift caused by external interference; and metal edge overlap of a mylar strip in the gantry that may create a sharp edge. The sharp edge defect may lead to repeat scanning and abrasions, but this specific issue does not apply to serial number 200036.
Healthcare professionals operating these systems should contact Shanghai United Imaging Healthcare Co., Ltd. for further instructions on how to address these defects.
The recalled product
- Product
- uMI 550 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 di
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 4
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 (3)
- Serial No.s 200017
- 200023
- 200024 and 200036.
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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