Shanghai United Imaging Healthcare Co., Ltd. recalled 22 units of its uCT 550 MD X-ray system on September 12, 2025. The recall was issued after reports that third-party outer covers can trap between the patient table and gantry. This can cause mechanical interference during table movement, posing a high risk to patients and healthcare providers.
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact UIH Technologies LLC or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Computed Tomography X-ray System, Model: uCT 550 MD. The affected serial numbers include 353020 through 354017. The product has been distributed in the U.S. and internationally.
Third-party outer covers can become trapped between the patient table and gantry. This interference can lead to improper table movement, increasing the risk of injury.
Currently, there have been no reported injuries or incidents associated with this recall. However, the potential for mechanical interference presents a serious hazard.
Healthcare providers and patients should stop using the device immediately. Contact UIH Technologies LLC or a healthcare provider for further instructions regarding the recall.
For more information, call UIH Technologies LLC. Details can also be found on the FDA recall notice.
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