Hitachi Medical Systems America Inc: Medical Device Recall in 2017 - (Recall #: Z-1096-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Hitachi Oasis MRI System - C-Spine Coil

Product Classification:

Class II

Date Initiated: January 6, 2017

Date Posted: February 1, 2017

Recall Number: Z-1096-2017

Event ID: 76056

Reason for Recall:

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

Status: Terminated

Product Quantity: 180 units

Code Information:

M001 to M028, M029 to M083, M085 to M090, M092 to M104, M106, M110 to M111, M113 to M114, M116 to M123, M125, M128 to M131, M133, M139 to M141, M143 to M147, M150, M152, M154, M159, M161, M163, M166, M169 to M176, M179, M182, M183, M185, M186, M190, M194 to 196, M201, M207 to M238

Distribution Pattern:

USA (nationwide) distribution. The product was distributed to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. There are three (3) government accounts for this recall: VA Medical Center/Lyster Army Health Clinic, Parma VA Medical Center, Outpatient Clinic. There are no Canada accounts for this recall. There are no Mexico accounts for this recall.

Voluntary or Mandated:

Voluntary: Firm initiated