BIOX
DigiMed Co., Ltd. · Model 1 · UDI-DI 08800021800045
Description
The portable x-ray system, BIOX is an x-ray generating device which is mainly designed for dental examination. So the device can be used in a hospital and a dental clinic as required. And with the advantage of the portability, it can be used for the military field or the people who have mobility difficulties. Users (operators) of the device should be at the skilled and well trained level of dentist, hygienist, radiologist, nurse, or a dental technician. Since the device generates radiation, it should be prescription use only. The device consists of control panel, high voltage generator, x-ray tube, rechargeable battery, charger, and software. And the device can be used with dental x-ray film, digital intraoral sensor, or phosphor plate to capture x-ray images.
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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