Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Hitachi Oasis MRI System - C-Spine Coil Recalled by Hitachi Medical Systems America Inc Due to The customer indicated that the coil balun was...

Date: January 6, 2017
Company: Hitachi Medical Systems America Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Hitachi Medical Systems America Inc directly.

Affected Products

Hitachi Oasis MRI System - C-Spine Coil

Quantity: 180 units

Why Was This Recalled?

The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Hitachi Medical Systems America Inc

Hitachi Medical Systems America Inc has 17 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report