| Reason for the Action |
The following problems were identified in the Operation Manual.
1. The XD2000 is not intended for handheld use, and the use of the supporting device is mandatory. However, the current Operation Manual contains statements that may cause confusion in terms of whether it is mandatory to use the supporting device, e.g. an “optional” holding device (Section 1.5.6)
2. The Operation Manual has been revised to include additional information on the impact of distance on the radiation dose to the operator.
3. The Operation Manual has been revised to include additional patient dosimetric information such as the radiation quantity for each intended use, and the description of the specified procedure to obtain these quantitative measurements.
4. The AC adapter was missing from the “Locations of Labels and Signs”.
If the appropriate distance from the X-ray generator cannot be maintained due to the above-mentioned problems, there is a risk of unintended exposure to radiation. This dose falls under the range of less than 1 mSv of exposure.
To date, no adverse events or customer complaints that are related to the above problems have been received. |