Reported Oct 29, 2025 · Ongoing
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550…
UIH Technologies LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: UIH Technologies LLC · 9380 Kirby Dr · Houston, TX · 77054-2515
Is this the product you have?
- Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography
- and Computed Tomography System ModeluMI 550 MD, Rx Only
- Lot codes and dates
- UDI(01)06971576832026/
- Serial Numbers
95 of 95 codes
200017200023200024200036200045200047230002230003230004230005230006230007230008230009230011230010230012230014230013200059230015230016230017230019230020230021230022230023230024230025232001200071230026230027200072230028200074230030230029200075200076230031230032230033230034230035200079200078230037230036230038230039230040230041230042230043230044230045230047230048
- Amount recalled
- 95 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Why it was recalled
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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