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Recall Observatory FDA recall evidence

Device product

Hitachi Oasis MRI System - C-Spine Coil

Z-1096-2017

January 06, 2017

Class II

Product summary

Firm
Hitachi Medical Systems America Inc
Event
Event 76056
Status
Terminated
Classification
Class II
Quantity
180 units
Official record key
device-enforcement:Z-1096-2017

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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