Home / Recalls / Hitachi Healthcare Americas Corporation / Z-2338-2021

Z-2338-2021 Class II Terminated

Recalled by Hitachi Healthcare Americas Corporation — Twinsburg, OH

Recall Details

Product Type: Devices
Report Date: September 1, 2021
Initiation Date: July 29, 2021
Termination Date: September 8, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 472 (US); 10 (OUS) Total

Product Description

ECHELON Oval MRI System

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.

Distribution Pattern

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

Code Information

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