Eos Imaging Recalls EOS Digital Radiography Systems Due to Filtration Alert Issue
Eos Imaging Inc is recalling 13 EOS digital radiography systems because a software alert regarding X-ray beam filtration may be suppressed, potentially leading to improper filtration during exams.
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: The recall is classified as FDA Class II. The hazard involves improper X-ray filtration, which is a risk-of-harm product issue where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Eos Imaging Inc is recalling 13 units of the EOS digital radiography system installed in the United States. The recall is due to a defect where an alert message regarding the spectral filtration of the X-ray beam may be suppressed during calibration. This suppression can result in improper filtration of the X-ray beam in examinations set up with copper filtration.
The affected units are distributed in the states of California, Delaware, Pennsylvania, Minnesota, Florida, Missouri, Ohio, Indiana, and Illinois. The product is identified by the model number EOS System. No specific lot numbers or serial numbers are provided in the source text.
Healthcare facilities using these systems should contact Eos Imaging Inc for further instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- EOS, Digital radiography system used in general radiographic examinations.
- Manufacturer
- Eos Imaging Inc
- Affected units
- 13
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)
- Model Number - EOS System
Distribution
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