United Imaging uCT 550 CT Systems Recalled for Sharp Metal Edges
Shanghai United Imaging Healthcare is recalling three uCT 550 Computed Tomography X-ray Systems because uneven metal edges on the mylar strip may create 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 risk-of-harm product (sharp edges) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling three units of the uCT 550 Computed Tomography X-ray System. The recall is due to a manufacturing defect where the metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
The affected units were distributed nationwide in the United States, including in California, Indiana, and Texas. The specific serial numbers for the recalled units are 353020, 353021, and 353023.
Healthcare facilities should contact Shanghai United Imaging Healthcare Co., Ltd. for instructions on how to address the defect. The source text does not report any injuries or illnesses associated with this recall.
The recalled product
- Product
- Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole…
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Hazard
- Affected units
- 3
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)
- SN 353020
- 353021
- 353023
Distribution
Part of a larger recall action
This product is one of 3 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.
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