CLASS II ONGOING Device recall · Reported 18 Nov 2020 · FDA Enforcement Report
Positron Emission Tomography and Computed Tomography System recalled
Shanghai United Imaging Healthcare is recalling Positron Emission Tomography and Computed Tomography 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-0448-2021
- FDA event ID
- 86269
- Recalling firm
- Shanghai United Imaging Healthcare, 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
- Other Reasons
- Device type
- Other Medical 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.
Product as listed by the FDA
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Where it was distributed
US Nationwide distribution including in the state of TX.
Questions about this recall
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: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 86269| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Computed Tomography X-Ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Other | Nationwide | |
| CLASS II | Computed Tomography X-Ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Other | Nationwide | |
| CLASS II | Computed Tomography X-Ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Other | Nationwide |
More recalls from Shanghai United Imaging Healthcare
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 | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | 4 states |
| Device | CLASS II | Digital Medical X-ray Imaging System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | uMI 550 System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Other | Nationwide |
| Device | CLASS II | uEXPLORER PET/CT System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Other | Nationwide |
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