Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
Summary
The FDA issued a Class II for Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, by UIH Technologies LLC. Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement..
Details
Source
Device Recall
External ID
Z-0217-2026
Action Date
2025-10-29
Status
Ongoing
Category
device
Product Description
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
Lot/Code Info: Serial Numbers: ; UDI: (01)06971576831012/ Serial Numbers: 300162 300163 300174 300176 304002 304003 304004 304006
Quantity Affected: 8 units
Reason for Recall
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Distribution
US: OUS:
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-12
Company
Houston, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 308 device recalls issued in the same week, part of 403 device-related FDA actions this month.
UIH Technologies LLC has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (UIH Technologies LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does UIH Technologies LLC have FDA actions?
UIH Technologies LLC has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0217-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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