HIGH

UIH Technologies Recalls PET/CT System Over Mechanical Hazard

Shanghai United Imaging Healthcare Co., Ltd. recalled four units of its Positron Emission Tomography and Computed Tomography System on September 12, 2025. The recall stems from a risk of mechanical interference during table movement due to third-party outer covers. Healthcare providers and patients must stop using the device immediately.

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brand
UIH Technologies
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact UIH Technologies LLC or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recall includes the uMI Panorama 35 model with serial numbers 11MI410003, 11MI410004, 11MI410005, and 20MI410001. The devices were distributed in the US and internationally. The classification of this recall is Class II.

The Hazard

Third-party outer covers can become trapped between the patient table and gantry. This interference can hinder the correct operation of the device, posing a mechanical risk during patient examinations.

Reported Incidents

No specific incidents or injuries have been reported as a result of this hazard. The recall aims to prevent potential mechanical issues before they occur.

What to Do

Stop using the device immediately. Follow recall instructions provided by the manufacturer. Contact UIH Technologies LLC or your healthcare provider for further instructions.

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0225-2026.

Key Facts

  • Recall date: September 12, 2025
  • Four units recalled
  • Class II recall classification
  • Risk of mechanical interference during use
  • Patients and healthcare providers should stop use immediately

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypePositron Emission Tomography and Computed Tomography System
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI: (01)06971576832170/ Serial numbers: 11MI410003
11MI410004
11MI410005
20MI410001
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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