Sectra Calibration Unit
Sectra AB · Model 2 · UDI-DI 07350092810395
8
510(k) clearances
8
Adverse events
2
Recalls
61
Facilities
Description
The Sectra Calibration Unit consists of calibration holders and markers. The calibration holders are intended to correctly place the calibration markers in relation to the patient during image acquisition. The calibration markers will be visible on the x-ray images and are intended to serve as scaling references. Typical users of the device are trained professionals, for example radiology technicians.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-08 | Landauer | Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot o |
| 2020-06-23 | Mevion Medical Systems, Inc. | The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer. |
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