Recall Z-2337-2021— Hitachi Healthcare Americas Corporation

Name: FDA recall Z-2337-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-29

Class II · Terminated

Class II FDA medical device recall by Hitachi Healthcare Americas Corporation, initiated 2021-07-29, terminated 2023-09-08. It names one FDA 510(k) clearance: K083533. Product: ECHELON MRI System. 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..

Recalling firm: Hitachi Healthcare Americas Corporation
Classification: Class II
Status: Terminated
Initiated: 2021-07-29
Terminated: 2023-09-08
Firm location: Twinsburg, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K083533 — ECHELON C MRI SYSTEMHitachi Medical Systems America, Inc.·cleared 2009-02-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ECHELON 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.