Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
FDA device recall Z-0218-2026 · posted 2025-10-21 · Open, Classified
Recall details
- Recalling firm
- UIH Technologies LLC
- Reason for recall
- Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- JAK
- Quantity affected
- 22 units
- Distribution
- US: OUS:
- Date initiated
- 2025-09-12
- Date posted
- 2025-10-21
- Location
- Houston, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| uCT 530, uCT 550 (K200016) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-02-25 |
| uCT 530, uCT 550 (K181414) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-08-14 |