United Imaging uCT 550 CT System Recalled for Image Artifacts
Shanghai United Imaging Healthcare is recalling three uCT 550 CT systems in Texas due to software issues that may cause image artifacts or scanning interruptions.
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 risk-of-harm product (radiation exposure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling three units of the uCT 550 Computed Tomography X-ray System. The recall affects serial numbers 353020, 353021, and 353023, all running software version R001.11.0.729741-Re-1100. These units were distributed to the state of Texas.
The recall was initiated because two issues were identified with the system. A service function may cause false marking of a bad channel, which can result in ring artifacts in the images. Additionally, the system may experience intermittent scout scanning interruptions due to occasional angle signal drift.
If these problems occur, it may be necessary to rescan the patient. This could result in an additional dose of radiation and the possible need for additional contrast medium. No injuries or illnesses have been reported in the source text.
The recalled product
- Product
- Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray…
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 3
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)
- Serial Numbers: 353020
- 353021
- and 353023 with software version R001.11.0.729741-Re-1100
Distribution
Distributed in 1 state:
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