United Imaging uCT 550 CT Scanners Recalled for Timer Display Error
Shanghai United Imaging Healthcare is recalling five uCT 550 CT scanners because an incorrect delay timer display may expose operators to unnecessary radiation.
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 (radiation exposure) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling five units of the Computed Tomography X-Ray System, Model uCT 550. The recall is due to a potential issue where an incorrect CT scan delay timer may be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning.
This display error could lead the operator to receive unnecessary exposure to radiation. The affected units were distributed nationwide in the United States, including in the state of Texas. The specific serial numbers for the recalled units are 353020, 353021, 353023, 353045, and 353049.
Healthcare facilities and operators should contact Shanghai United Imaging Healthcare Co., Ltd. for instructions on how to resolve the issue. The source text does not specify a particular action for consumers, as the product is a prescription medical device intended for professional use.
The recalled product
- Product
- Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body…
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 5
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 (5)
- Serial Numbers: 353020
- 353021
- 353023
- 353045
- 353049
Distribution
Part of a larger recall action
This product is one of 4 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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