X-ray system displays incorrect collimation area information
The YSIO X.Pree x-ray system's user interface displays incorrect collimation information during image acquisition. While actual collimation functions correctly, the display does not match preset parameters, potentially confusing operators.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The issue is a user interface indication problem where the displayed collimation area does not match actual collimation, but the actual x-ray function is correct. This falls under minor labeling or indication errors.
Plain-English summary
The YSIO X.Pree is an automated multi-image x-ray acquisition system manufactured by Siemens Medical Solutions USA, Inc. The recall involves 53 units distributed nationwide and worldwide.
During automated x-ray examination procedures, the collimation area displayed on the user interface does not correctly represent the actual x-ray collimation area specified by the system. The display shows a wider collimation area than what was preset for the examination. However, the actual x-ray collimation is performed correctly and matches the examination area predefined by the user.
This discrepancy between the displayed collimation area and the actual collimation could potentially cause operator confusion about the imaging area during the examination. Healthcare facilities using this equipment should review the recall notice from Siemens Medical Solutions and follow the manufacturer's instructions for addressing this issue.
The recalled product
- Product
- YSIO X.Pree
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 53
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)
- 11107464
Distribution
Distributed nationwide across the United States.
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