uMI 550 PET systems recalled because third party covers can jam
UIH Technologies is recalling 95 uMI 550 PET/CT systems because third-party outer covers can become trapped between the patient table and gantry.
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 uMI 550 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 95 units carrying UDI 06971576832026, with serial numbers including 200017, 200023, 200024, 200036, 200045, 200047 and 230002 through 230005. 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:uMI 550 MD, Rx Only
- Manufacturer
- UIH Technologies LLC
- Category
- Medical Device — PET CT system
- Hazard
- mechanical-interference
- third-party-accessory
Distribution
Distribution scope not specified by the agency.
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