Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brand
- UIH Technologies
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- UIH Technologies
- Product type
- Positron Emission Tomography and Computed Tomography System
- Model numbers
- 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
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 12, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact UIH Technologies LLC or your healthcare provider for instructions. Notification method: Letter
About This Product
The uMI 550 MD PET/CT system is a medical imaging device used for combined PET and CT scans in clinical settings. It is used by hospitals and imaging centers for diagnostic imaging.
Why This Is Dangerous
A third-party outer cover can become trapped between the patient table and gantry, causing mechanical interference during table movement. This may affect imaging procedures or cause patient risk if the table moves unexpectedly.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
The issue can interrupt imaging workflows and potentially disrupt patient positioning or image quality until resolved.
Practical Guidance
How to identify if yours is affected
- Check device label for model uMI 550 MD and UDI (01)06971576832026.
- Compare serial numbers against the listed list in the recall notice.
- Review the FDA recall page for exact serial numbers and instructions.
Where to find product info
Identifiers are on the device label and data plate. See the FDA recall page for the full serial-number list.
What timeline to expect
Remedy processing timelines are determined by the manufacturer; the recall page does not specify a timetable.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer.
- Consider filing a safety report with the appropriate regulatory body if the manufacturer remains unresponsive.
How to prevent similar issues
- Use only manufacturer-approved outer covers or avoid third-party covers that could interfere with gantry movement.
- Inspect covers before each scan to ensure nothing is trapped in the space between the table and gantry.
- Maintain up-to-date device documentation and recall notices for audits.
Documentation advice
Keep the recall letter, record all communications with the manufacturer and healthcare facility, and photograph the device label and covers.
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Product Details
Model: uMI 550 MD. Classification: Class II. Quantity: 95 units. Distribution: United States. Distributor/Manufacturer: Shanghai United Imaging Healthcare Co., Ltd. Recall date: 2025-09-12.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model: uMI 550 MD
- Remedy involves manufacturer instructions; no specific refund details provided
- FDA recall page link included
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Safety Guide
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