PET CT systems recalled because third party covers can trap during movement
UIH Technologies is recalling two uEXPLORER PET/CT systems because third-party outer covers can become trapped between the patient table and gantry, causing mechanical interference.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record describes mechanical interference during table movement without stating a hazard, patient consequence or reported harm.
Plain-English summary
The uEXPLORER Positron Emission Tomography and Computed Tomography System from Shanghai United Imaging Healthcare is being recalled.
Third-party outer covers can become trapped between the patient table and the gantry, causing mechanical interference during table movement.
The recall covers two units carrying UDI 06971576832040, serial numbers F00002 and F00015. The FDA has classified the action as Class II.
The enforcement record describes the interference and does not state any injury or patient consequence. Sites operating affected serial numbers should follow the firm's instructions.
The recalled product
- Product
- Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only
- Manufacturer
- UIH Technologies LLC
- Category
- Medical Device — PET CT system
- Hazard
- mechanical-interference
- third-party-accessory
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)
- UDI: (01)06971576832040
- Serial Number: F00002
- F00015
Distribution
Distribution scope not specified by the agency.
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