The Recall Desk
ModerateFDA (Devices)·Z-1541-2017·Announced 2017-03-29

Hitachi Echelon Oval MRI System Recalled for Image Data Errors

Hitachi Medical Systems America Inc is recalling 25 Hitachi Echelon Oval 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, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a data error in image transfer, which is a functional defect rather than a direct physical safety risk like fire or shock, fitting the criteria for a moderate severity recall involving low-risk issues or voluntary precautionary measures.

Plain-English summary

Hitachi Medical Systems America Inc is recalling 25 units of the Hitachi Echelon Oval 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 distribution also included two accounts in Mexico and one account in Brazil. Four government accounts in the United States were also affected, including facilities in Alabama, Ohio, Florida, and Maryland.

No specific instructions for consumers are provided in the source text. The recall number is Z-1541-2017.

The recalled product

Product
Hitachi Echelon Oval MRI System
Manufacturer
Hitachi Medical Systems America Inc
Category
Medical Device — MRI System
Hazard
Affected units
25

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)

  • Y001
  • Y002
  • Y003
  • Y004
  • Y005
  • Y006
  • Y007
  • Y008
  • Y009
  • Y010
  • Y011
  • Y012
  • Y013
  • Y014
  • Y015
  • Y016
  • Y101
  • Y102
  • Y103
  • Y104

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 →

Related recalls

Same manufacturer · Hitachi Medical Systems America Inc

See all →

Same hazard · data error

See all →