Hitachi Oasis MRI System Recalled for Image Data Transfer Errors
Hitachi Medical Systems America Inc is recalling 210 Hitachi Oasis MRI Systems because image data transferred to workstations showed errors on the slice position reference image.
What this means for you
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. The source text describes a data transfer error regarding the slice position reference image but does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving potential diagnostic errors without reported harm.
Plain-English summary
Hitachi Medical Systems America Inc is recalling 210 units of the Hitachi Oasis MRI System. The recall was initiated because image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
The affected products were distributed nationwide in the United States to 49 states and the District of Columbia, as well as to Puerto Rico. The recall also includes four government accounts in the US, two accounts in Mexico, and distribution to Brazil. The specific model codes affected range from M001 to M210, as well as M951 and M952.
This is an FDA Class II recall. No specific instructions for consumers are provided in the source text, but the defect involves data integrity issues with the slice position reference image.
The recalled product
- Product
- Hitachi Oasis MRI System
- Manufacturer
- Hitachi Medical Systems America Inc
- Category
- Medical Device — MRI System
- Hazard
- Affected units
- 210
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 (20)
- M001
- M002
- M003
- M004
- M005
- M006
- M007
- M008
- M009
- M010
- M011
- M012
- M013
- M014
- M015
- M016
- M017
- M018
- M019
- M020
Distribution
Part of a larger recall action
This product is one of 3 recalled by Hitachi Medical Systems America Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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