Reported Jul 8, 2020 · Ongoing
uCT 530 Computed Tomography X-Ray System
Shanghai United Imaging Healthcare Co., Ltd.
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: Shanghai United Imaging Healthcare Co., Ltd. · No. 2258 Chengbei Rd, Jiading Ind. · Shanghai, N/A · N/A
Is this the product you have?
- uCT 530 Computed Tomography X-Ray System
- Lot codes and dates
- Units with software version no. R001.11.0.729741-Re-1100
- including the followingSerial
- number/GTIN
300162 (GTIN: 6971576831012)300163 (GTIN: 6971576831012)300174 (GTIN: 6971576831012)
- and 300176 (GTIN6971576831012)
- Amount recalled
- 4 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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