Skip to content
Recall Observatory FDA recall evidence

Device product

ECHELON MRI System

Z-2337-2021

July 29, 2021

Class II

Product summary

Firm
Hitachi Healthcare Americas Corporation
Event
Event 88452
Status
Terminated
Classification
Class II
Quantity
472 (US); 10 (OUS) total
Official record key
device-enforcement:Z-2337-2021

Official wording

Reason: There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.

Code information: V001-V070, V952

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.