Hitachi Medical Systems America Inc: Medical Device Recall in 2014 - (Recall #: Z-2564-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.

Product Classification:

Class II

Date Initiated: August 18, 2014

Date Posted: September 10, 2014

Recall Number: Z-2564-2014

Event ID: 68758

Reason for Recall:

The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.

Status: Terminated

Product Quantity: 39 systems

Code Information:

Product Codes: Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y014, Y015, Y016, Y101, Y102, Y103, Y105, and Y951. To be updated as firm submits information.

Distribution Pattern:

Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, ID, KS, KY, MD, MS, NY, OH, and WY; countries of: Japan, Brazil, France, Germany, and Kyrgyzstan.

Voluntary or Mandated:

Voluntary: Firm initiated