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PROX

DigiMed Co., Ltd. · Model 1 · UDI-DI 08800021800007

EHD Prescription

510(k) clearances

521

Adverse events

Recalls

Facilities

Description

The PROX is a hand-held diagnostic dental x-ray system. It 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. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The system helps to get sharp and clear x-ray images, and its low radiation dosage keeps patients and dentists safe from leakage radiation.

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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.