International safety notice
In versions 1.3.0 and 1.3.2 of the target product's software "StealthStation S8 Application", spyware It has been discovered that the following two problems may occur during the procedure. Problems (1) Problems related to navigation direction: When using Ziehm Vision FD Vario 3D X-ray fluoroscopic diagnostic equipment, When taking a perspective view, the navigation direction displayed on the system may be reversed. Problem (2) Problem related to pop-up message: CT images and fluoroscopic images where the thickness of the slice interval exceeds the recommended value The system no longer displays a pop-up message indicating that the slice spacing is not optimal when using There is a possibility that We will collect the recording media (CDs) of the software in which this defect has been confirmed, and if the affected software version is installed. For systems that were confirmed to be installed, we implemented a software upgrade that fixed the problem. I will.
Japan / PMDA Recalls · JPN · Sep 3, 2024
Key facts
| Title | In versions 1.3.0 and 1.3.2 of the target product's software "StealthStation S8 Application", spyware It has been discovered that the following two problems may occur during the procedure. Problems (1) Problems related to navigation direction: When using Ziehm Vision FD Vario 3D X-ray fluoroscopic diagnostic equipment, When taking a perspective view, the navigation direction displayed on the system may be reversed. Problem (2) Problem related to pop-up message: CT images and fluoroscopic images where the thickness of the slice interval exceeds the recommended value The system no longer displays a pop-up message indicating that the slice spacing is not optimal when using There is a possibility that We will collect the recording media (CDs) of the software in which this defect has been confirmed, and if the affected software version is installed. For systems that were confirmed to be installed, we implemented a software upgrade that fixed the problem. I will. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Neurosurgical navigation unit Sales name: Stealth Station S8 |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | 0010646353, 0010410541, 0010421277, N31189942, N30808865, N30001588, N29553207, N29900709, 0010585398, N31104179, 0010944063, N30038959 and 401 more |
| Date | Sep 3, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1