MiniX-S
DigiMed Co., Ltd. · Model 1 · UDI-DI 08800021800021
Description
The MiniX-S is an x-ray generating device which is mainly designed for dental examination. The device has an x-ray tube for generating x-rays, a high voltage transformer for generating high voltages, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to low voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, saving and displaying the data, a power P.C.B for supplying power to the circuit and apparatus in housing, user interface (LCD screen) and beam limiting part (x-ray emitting cone). The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patients and users from unnecessary exposure of radiation. The device is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray images using with intra-oral image receptors. Its use is intended for adults and pediatric subjects both.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-19 | DIGIMED CO., LTD | Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm. |
| 2017-07-14 | Panoramic Rental Corp. | The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule. |
| 2016-08-19 | Panoramic Rental Corp. | Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffective, which could resu |
| 2016-07-18 | Aribex Inc | Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that |
| 2016-07-18 | Aribex Inc | Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that |
| 2015-06-04 | Panoramic Rental Corp. | Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury. |
| 2014-08-12 | Gendex Corp | Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle |
| 2014-01-24 | Carestream Health Inc. | Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. |
| 2014-01-24 | Carestream Health Inc. | Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. |
| 2014-01-14 | Instrumentarium Dental, PaloDEx Group Oy | Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray units in November 2013 with a potential flaw in the mounting hardware. A number of wall mount units were |
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