Hitachi Healthcare Americas Corporation: Medical Device Recall in 2021 - (Recall #: Z-2338-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

ECHELON Oval MRI System

Product Classification:

Class II

Date Initiated: July 29, 2021

Date Posted: September 1, 2021

Recall Number: Z-2338-2021

Event ID: 88452

Reason for Recall:

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.

Status: Terminated

Product Quantity: 472 (US); 10 (OUS) Total

Code Information:

Y001-Y016, Y051-Y068, Y101-Y169, Y951

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated