Hitachi MRI Software Recall for Image Orientation Error
Hitachi is recalling MRI software due to a defect that may reverse the orientation of the first image in a dataset.
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 involves a risk-of-harm product (medical imaging) where the defect could lead to diagnostic errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Hitachi Medical Systems America Inc. is recalling software for the Echelon and Oasis MRI systems. The recall involves 165 units distributed nationwide in the United States and in Mexico. The affected software versions are Echelon V001 through V061 and Oasis M001 through M105, plus M951.
The recall is due to a software error in the Multi-Planar Reconstruction (MPR) feature. This feature creates new image sets from different views of the original data. The error can randomly cause the first image in the dataset to have a reversed right/left orientation. This defect may affect the accuracy of the images provided to physicians for diagnosis.
Healthcare facilities using these systems should contact Hitachi Medical Systems America Inc. for instructions on how to resolve the software error. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis…
- Manufacturer
- Hitachi Medical Systems America Inc
- Category
- Medical Device — MRI Software
- Affected units
- 165
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 (6)
- Echelon
- V001 through V061
- inclusive. Oasis
- M001 through M105
- inclusive
- M951
Distribution
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