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Open, Classified

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only

FDA Recall Z-0221-2026 · Posted 2025-10-21

Recalling FirmUIH Technologies LLC
Recall StatusOpen, Classified
Product CodeJAK
Date Initiated2025-09-12
Product Quantity2 units

Reason for Recall

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

Firm Action

On September 12, 2025, UIH Technologies LLC, issued a recall notification to affected consignees. UIH asked consignees to take the following actions: 1. Ensure patient positioning clearance: When positioning the patient, confirm that arms and legs and clear of all table gaps and moving parts. 2. Avoid use of third-party slickers: We advise against the use of any non-UIH-approved slickers. 3. Service Contact: For technical assistance, contact your United Imaging Service engineer or reach out to our 24/7 Customer Contact Center, Toll-Free: (855) 221-1552/Direct: (832) 699-2799 4.Report adverse events: if any adverse events or quality issue occur, please report them to the FDA via the MedWatch program. 5. Please share this information with all relevant personnel at your facility, including technologist, service staff, and clinical teams.

Root Cause

Other

Distribution Pattern

US: OUS:

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K243617uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · 2025-05-16K231482uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · 2023-11-29K203448uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · 2021-08-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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