CLASS II ONGOING Device recall · Reported 18 Nov 2020 · FDA Enforcement Report
Computed Tomography X-Ray System recalled by Shanghai United Imaging
Shanghai United Imaging Healthcare Co is recalling Computed Tomography X-Ray System, distributed nationwide in the US. The recall was initiated on 5 Aug 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0447-2021
- FDA event ID
- 86269
- Recalling firm
- Shanghai United Imaging Healthcare Co, Shanghai
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Aug 2020
- FDA classified
- 12 Nov 2020
- Reported
- 18 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Lead & Heavy Metals
- Device type
- Heart & Vascular Devices
Timeline
| 5 Aug 2020 | Recall initiated by company | |
| 12 Nov 2020 | Classified by FDA | +99 days |
| 18 Nov 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).
Where it was distributed
US Nationwide distribution including in the state of TX.
Questions about this recall
Is Computed Tomography X-Ray System recalled?
Yes. Shanghai United Imaging Healthcare Co recalled Computed Tomography X-Ray System on 5 Aug 2020. The recall is Class II and its status is Ongoing. Recall number Z-0447-2021.
Why was it recalled?
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
Which lots are affected?
Serial Numbers: 600229, 600230, 600232, 600271, 600282
Where was it sold?
US Nationwide distribution including in the state of TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Shanghai United Imaging Healthcare Co
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ltd Positron Emission Tomography (PET) and Computed Tomography (CT) recalled | Shanghai United Imaging Healthcare Co | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare Co | Device Malfunction | 4 states |
| Device | CLASS II | Digital Medical X-ray Imaging System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare Co | Labeling Errors | Nationwide |
| Device | CLASS II | uMI 550 System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare Co | Other | Nationwide |
| Device | CLASS II | uEXPLORER PET/CT System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare Co | Other | Nationwide |
Other Heart & Vascular Devices recalls
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |