United Imaging uCT 530 CT System Recalled for Sharp Metal Edge
Shanghai United Imaging Healthcare is recalling four uCT 530 Computed Tomography X-ray Systems because uneven metal edge overlap may create a sharp edge.
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 medical device with a physical defect that may create a sharp edge, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling four units of the uCT 530 Computed Tomography X-ray System. The recall is due to a defect where the metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
The affected units are distributed nationwide in the United States, including in California, Indiana, and Texas. The specific serial numbers for the recalled units are 300162, 300163, 300174, and 300176.
Healthcare facilities should contact the manufacturer for further instructions regarding the recall and corrective actions for the identified units.
The recalled product
- Product
- Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - 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
- 4
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 (4)
- SN 300162
- 300163
- 300174
- 300176
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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