Hitachi Recalls Echelon and Oasis MR Imaging Systems Due to Software Error
Hitachi is recalling 45 Echelon, Echelon Oval, and Oasis MR imaging systems due to a software error that can cause image data loss during simultaneous scanning and processing.
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: The recall is classified as FDA Class II, but the hazard involves data integrity (image loss) rather than direct physical injury or death, fitting the criteria for moderate severity involving low-risk operational errors.
Plain-English summary
Hitachi Medical Systems America Inc is recalling 45 units of Echelon, Echelon Oval, and Oasis MR imaging device systems. The recall is due to a software error that can occur randomly when a patient is being scanned while images from a different patient are being processed. This error causes an image in the processed dataset to have the same unique identifier (UID) as the scanning dataset, resulting in the processed image overwriting and losing the original image.
The affected systems were distributed worldwide, including nationwide in the United States and one unit in Mexico. Specific serial numbers associated with the recall are listed in the agency documentation. The MR systems are intended to provide physicians with physiological and clinical information non-invasively.
Healthcare facilities should contact Hitachi Medical Systems America Inc for instructions on how to resolve the software error. Consumers are not directly affected as these are professional medical devices.
The recalled product
- Product
- Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use…
- Manufacturer
- Hitachi Medical Systems America Inc
- Hazard
- Affected units
- 45
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 (10)
- The following serial numbers are associated with this recall: Echelon - V061
- V062
- and V065 Oasis - M009
- M017
- M067
- M071
- M084
- M106-M108
- M110-M141 inclusive
- and M952 Echelon Oval - Y001-Y005 inclusive
Distribution
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