EOS Imaging Recalls EOS System X-ray Digital Radiography Devices
EOS Imaging is recalling 22 EOS System X-ray digital radiography units installed in the US due to a discrepancy between the operator-set collimation and the actual X-ray beam collimation.
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: The recall involves a medical device with a functional defect affecting X-ray beam collimation, which poses a risk of harm (incorrect exposure or imaging) even though no specific injuries are reported in the source text.
Plain-English summary
EOS Imaging is recalling 22 EOS System X-ray digital radiography units installed in the United States. The recall was initiated after the manufacturer discovered during internal production testing that the X-ray beam collimation set by the operator at the user interface differs from the actual collimation of the X-ray beam operated by the system during acquisition.
The affected devices are used for general radiographic examinations. The discrepancy in collimation settings means the X-ray beam may not match the parameters intended by the operator. The recall is distributed nationwide.
Consumers and healthcare facilities with these devices should contact EOS Imaging for further instructions on how to address the issue.
The recalled product
- Product
- EOS System X- ray beam Digital radiography system used in general radiographic examinations.
- Manufacturer
- EOS Imaging
- Category
- Medical Device — Radiography
- Affected units
- 22
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)
- EOS System
Distribution
Distributed nationwide across the United States.
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