Device recall: Computed Tomography X-ray System, Model: uCT 530 with software
Class II FDA enforcement event 99731. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Shanghai United Imaging Healthcare Co., Ltd. started this device recall on 11 Aug 2026. The firm address in the FDA record is in Shanghai. FDA put the recall in Class II. FDA event 99731 has 12 product records. The first FDA enforcement report date is 7 Oct 2026. The record gives the status Ongoing. 31 of the 677 device events that started in 2026 have more product records. The median device event of 2026 has 1 product record.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.
Recalling firm
Shanghai United Imaging Healthcare Co., Ltd., Shanghai, China.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3277-2026 | Computed Tomography X-ray System, Model: uCT 530 with software | 4 | Class II | Ongoing | 7 Oct 2026 |
| Z-3278-2026 | Computed Tomography X-ray System, Model: uCT 550 with software | 23 | Class II | Ongoing | 7 Oct 2026 |
| Z-3279-2026 | Computed Tomography X-ray System, Model: uCT 760 with software | 1 | Class II | Ongoing | 7 Oct 2026 |
| Z-3280-2026 | Computed Tomography X-ray System, Model: uCT 780 with software | 14 | Class II | Ongoing | 7 Oct 2026 |
| Z-3281-2026 | Computed Tomography X-ray System, Model: uCT ATLAS with software | 11 | Class II | Ongoing | 7 Oct 2026 |
| Z-3282-2026 | Computed Tomography X-ray System, Model: uCT ATLAS Astound with software | 53 | Class II | Ongoing | 7 Oct 2026 |
| Z-3283-2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software | 34 | Class II | Ongoing | 7 Oct 2026 |
| Z-3284-2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software | 7 | Class II | Ongoing | 7 Oct 2026 |
| Z-3285-2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software | 3 | Class II | Ongoing | 7 Oct 2026 |
| Z-3286-2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software | 3 | Class II | Ongoing | 7 Oct 2026 |
| Z-3287-2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software | 6 | Class II | Ongoing | 7 Oct 2026 |
| Z-3288-2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI 780 | 1 | Class II | Ongoing | 7 Oct 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 677
- Share of these events in Class II
- 87%
- Product records in this event
- 12Median of the firm: 1
- Events of the firm on the register
- 15
Other events of the firm
Official channels
- FDA enforcement report Z-3277-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 99731. https://recallregister.com/fda/ii/99731/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 27 Oct 2026
- Newest FDA report date on the register
- 21 Oct 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.
- What quantity of product is in FDA event 99731?
- The event has 12 product records. The first record gives this quantity:
4
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 87% of the 677 device events that started in 2026 are in Class II.