The Recall Desk
ModerateFDA (Devices)·Z-1542-2017·Announced 2017-03-29

Hitachi Echelon MRI System Recalled for Image Data Transfer Errors

Hitachi Medical Systems America Inc is recalling 68 Hitachi Echelon 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, and the source text describes a data transfer error without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving potential risk but no reported harm.

Plain-English summary

Hitachi Medical Systems America Inc is recalling 68 units of the Hitachi Echelon 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 48 states and the District of Columbia, as well as to Puerto Rico. The recall also includes four government accounts in the U.S., two accounts in Mexico, and distribution to Brazil. The specific serial codes affected are V001 through V068 and V952.

No specific consumer action is detailed in the source text beyond the recall notice. Healthcare facilities and users should refer to the official FDA recall notice for specific remediation instructions.

The recalled product

Product
Hitachi Echelon MRI System
Manufacturer
Hitachi Medical Systems America Inc
Category
Medical Device — MRI System
Hazard
Affected units
68

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)

  • V001
  • V002
  • V003
  • V004
  • V005
  • V006
  • V007
  • V008
  • V009
  • V010
  • V011
  • V012
  • V013
  • V014
  • V015
  • V016
  • V017
  • V018
  • V020
  • V021

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

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.

See all 3 products in this recall →

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