Z-0223-2026Class II

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System...

Name: Z-0223-2026 Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System...
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. Positron Emission Tomography and Computed Tomography System Model:uMI 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-0223-2026
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. Positron Emission Tomography and Computed Tomography System Model:uMI 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: 95 units
Distribution: US: OUS:
Product codes and lots: UDI: (01)06971576832026/ Serial Numbers: 200017 200023 200024 200036 200045 200047 230002 230003 230004 230005 230006 230007 230008 230009 230011 230010 230012 230014 230013 200059 230015 230016 230017 230019 230020 230021 230022 230023 230024 230025 232001 200071 230026 230027 200072 230028 200074 230030 230029 200075 200076 230031 230032 230033 230034 230035 200079 200078 230037 230036 230038 230039 230040 230041 230042 230043 230044 230045 230047 230048 232002 202002 232003 232004 232005 230057 232006 232007 202004 232008 232009 202005 232010 202006 232011 202007 232012 232013 232014 230067 230068 230069 232015 232016 230070 230071 230073 202008 230072 230074 232017 202009 232018 232019 202010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0223-2026
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)