Z-0218-2026Class II

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only

Name: Z-0218-2026 Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
Creator: UIH Technologies LLC
Published: 2025-09-12
License: https://open.fda.gov/license/

UIH Technologies LLC / initiated 2025-09-12 / Open, Classified

FDA source

UIH Technologies LLC began a recall of Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only on 2025-09-12. FDA classified it as Class II and gives the reason as "Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0218-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-12
Posted: 2025-10-21
Recalling firm: UIH Technologies LLC
Product: Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
FDA root cause: Other
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.
Quantity in commerce: 22 units
Distribution: US: OUS:
Product codes and lots: UDI:(01)06971576831036/ Serial Numbers: 353020 353021 353023 353045 353049 354001 354002 354003 354004 354005 354006 354007 354008 354009 354010 354011 354012 354013 354014 354015 354016 354017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0218-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0217-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-21
Z-0218-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-21
Z-0219-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-21
Z-0220-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-21
Z-0221-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-21
Z-0222-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-21
Z-0223-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-21
Z-0224-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-21
Z-0225-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-21

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)