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.
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 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…
- 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Shanghai United Imaging Healthcare Co., Ltd.
See all →- ModerateUnited Imaging uCT ATLAS CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panorama GS PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging CT System Recall Due to Software Image Visibility Issue
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 760 CT System Recalled for Software Visibility Issue
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Same hazard · sharp edge
See all →- HighOBP Medical Recalls Vaginal Speculums Due to Potential Sharp Edges
FDA (Devices) · 2026-08-19
- HighMRI Machine Coil Seal Adhesive May Create Sharp Edges
FDA (Devices) · 2024-02-07
- SevereMedline Nursing Skills Kit: Tracheostomy Brush Sharp Edge and Bristle Defect
FDA (Devices) · 2024-01-03
- SevereMedline Tracheostomy Care Kits Recalled for Sharp Brush and Bristle Detachment
FDA (Devices) · 2024-01-03
- SevereMedline Nurse Training Kits Recalled for Sharp Tracheostomy Brush
FDA (Devices) · 2024-01-03
Similar recalls
- HighUnited Imaging uCT 550 CT Systems Recalled for Sharp Metal Edges
FDA (Devices) · 2020-08-05
- HighUnited Imaging uCT 530 CT System Recalled for Sharp Metal Edge
FDA (Devices) · 2020-08-05
- ModerateUnited Imaging uMI 550 PET/CT System Recalled for Software Bugs
FDA (Devices) · 2020-04-22
- HighUnited Imaging uMI 550 PET/CT System Recalled for Incorrect CT Scan Delay Timer
FDA (Devices) · 2020-11-18
- HighPET/CT Imaging System Recall: Software Issue Prevents Image Reconstruction
FDA (Devices) · 2023-04-19
- HighUnited Imaging uCT 760 CT Systems Recalled for Sharp Metal Edges
FDA (Devices) · 2020-08-05