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.
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 2/5 (Moderate).
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
- Affected units
- 2
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.
Part of a larger recall action
This product is one of 9 recalled by UIH Technologies LLC 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 9 products in this recall →Related recalls
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