United Imaging uCT 530 CT System Recalled for Scanning Interruptions
Shanghai United Imaging Healthcare is recalling four uCT 530 Computed Tomography X-Ray Systems in Texas due to software issues that may cause scanning interruptions or image artifacts.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a defect may lead to additional radiation exposure and contrast medium administration, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling four units of the uCT 530 Computed Tomography X-Ray System. These units were distributed to Texas and are identified by specific serial numbers and software version R001.11.0.729741-Re-1100.
The recall addresses two software-related issues: a service function that may cause false marking of a bad channel, resulting in ring artifacts, and potential intermittent scout scanning interruptions due to occasional angle signal drift. If these problems occur, patients may require rescanning, which results in an additional dose of radiation and the possible need for additional contrast medium.
No injuries or illnesses have been reported in connection with this recall. Healthcare facilities should contact the manufacturer for instructions on software updates or repairs.
The recalled product
- Product
- uCT 530 Computed Tomography X-Ray System
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 300163 (GTIN: 6971576831012)
- 300174 (GTIN: 6971576831012)
- and 300176 (GTIN: 6971576831012).
Distribution
Distributed in 1 state:
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