CUBEscan
Mcube Technology Co.,Ltd · Model BioCon-500 · UDI-DI 08809458500023
Description
The BioCon-500 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-500 transmits ultrasound signals to the abdomen of a patient and receives the echoed signals. Using the echoed signals the system detects the bladder outlines and calculates the volume in bladder outlines. BioCon-500 has a Pre-Scan function, which shows the ultrasound images for a horizontal plane consisted of the echoed signals. The Pre-Scan function helps a user locate the bladder easily and get more accurate results. A user can print the results using a built-in thermal printer after measurements right away. Also using the optional CubeScanPC software you can upload the saved data in a device's flash ROM to a computer for reviewing the scan results.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified |
| 2026-03-02 | Civco Medical Instruments Co. Inc. | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified |
| 2022-01-24 | Volcano Corp | Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique |
| 2021-11-04 | GE Healthcare, LLC | The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connec |
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