EOS Imaging Recalls steroEOS Workstation Due to Data Copying Error
EOS Imaging is recalling 36 steroEOS Workstation units because a software error may prevent 3D model data from copying to clinical files and reports.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
EOS Imaging is recalling 36 units of the steroEOS Workstation, a system used for the acceptance, transfer, display, and digital processing of 3D X-ray images. The recall involves software versions 1.3, 1.4, and 1.5. The product was distributed nationwide in the United States.
The recall is being conducted because of a software error that occurs when two 3D models are opened simultaneously on the workstation. This error can prevent information from being correctly copied to the clinical file and the report. The source text does not report any specific patient injuries or illnesses associated with this defect.
Healthcare facilities and users of the steroEOS Workstation should contact EOS Imaging for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA, indicating that the use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
- Manufacturer
- EOS Imaging
- Affected units
- 36
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 (2)
- Software versions: 1.3
- 1.4 and 1.5
Distribution
Distributed nationwide across the United States.
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