Class II — Potential Health Hazard

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

Oasis Coil Extension Cable used with Hitachi Oasis MRI System Recalled by Hitachi Medical Systems America Inc Due to The firm received a complaint stating the Coil...

Date: April 25, 2014
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

Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. The Coil Extension Cable that is the subject of the removal action is an accessory that is used in conjunction with certain anatomy coils to aid in patient positioning.

Quantity: 173 units

Why Was This Recalled?

The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.

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