DIOX-602 portable x-ray units do not meet the minimum source-to-skin distance
Some DIOX-602 portable x-ray systems in use in the United States do not meet the minimum source-to-skin distance requirement of 18 cm. 530 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Risk-of-harm product: a radiation safety parameter that limits patient skin dose is not met, with no injury reported in the source.
Plain-English summary
The DIOX-602 portable x-ray system, UDI-DI 08800021800014, is being recalled. The action covers 530 units.
The stated reason is that some DIOX-602 units currently in use within the United States do not meet the minimum source-to-skin distance requirement of 18 cm. The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was in the United States. The systems are used by healthcare and dental facilities rather than sold to consumers.
Facilities should identify affected units using the model name and UDI-DI above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Portable X-ray system
- Manufacturer
- DIGIMED CO., LTD
- Affected units
- 530
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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