CLASS II ONGOING Device recall · Reported 8 Jul 2020 · FDA Enforcement Report
uCT 530 Computed Tomography X-Ray System recalled
Shanghai United Imaging Healthcare is recalling uCT 530 Computed Tomography X-Ray System, distributed in Texas. The recall was initiated on 8 May 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-2472-2020
- FDA event ID
- 85809
- Recalling firm
- Shanghai United Imaging Healthcare, Shanghai, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 May 2020
- FDA classified
- 30 Jun 2020
- Reported
- 8 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 8 May 2020 | Recall initiated by company | |
| 30 Jun 2020 | Classified by FDA | +53 days |
| 8 Jul 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.
Product as listed by the FDA
uCT 530 Computed Tomography X-Ray System
Where it was distributed
Distributed to Texas.
Questions about this recall
Why was it recalled?
Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.
Which lots are affected?
Units with software version no. R001.11.0.729741-Re-1100 including the following: Serial number/GTIN: 300162 (GTIN: 6971576831012); 300163 (GTIN: 6971576831012); 300174 (GTIN: 6971576831012); and 300176 (GTIN: 6971576831012).
Where was it sold?
Distributed to Texas.
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.
More recalls from Shanghai United Imaging Healthcare
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|---|---|---|---|---|---|
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