Portable X-ray systems recalled for inadequate radiation safety spacing
Certain DIGIMED DIOX-602 portable X-ray systems do not meet the minimum source-to-skin distance safety requirement of 18 centimeters. This non-compliance may increase patient radiation exposure during diagnostic imaging.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device where affected units fail to meet minimum source-to-skin distance safety specifications. No illnesses or injuries have been reported in the source text. This qualifies as a risk-of-harm product where injury has not yet been reported, warranting High severity per the rubric.
Plain-English summary
DIGIMED CO., LTD is recalling certain DIOX-602 portable X-ray systems currently in use in the United States. The affected units do not meet the minimum Source-to-Skin Distance (SSD) requirement of 18 centimeters.
Source-to-Skin Distance is a critical radiation safety specification that determines the minimum safe distance between the X-ray source and the patient's skin. X-ray systems that do not meet this requirement may expose patients to higher levels of radiation than intended during diagnostic imaging.
Healthcare facilities and imaging centers using these systems should verify that their equipment meets the 18 centimeter minimum SSD requirement. Contact DIGIMED CO., LTD for instructions on remediation if your units do not meet this safety specification.
The recalled product
- Product
- Portable X-ray system
- Manufacturer
- DIGIMED CO., LTD
- Hazard
- radiation-overexposure
- inadequate-spacing
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI/Model Name: 08800021800014/DIOX-602
Distribution
Distribution scope not specified by the agency.
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