Device product
Hitachi Oasis MRI System - C-Spine Coil
Z-1096-2017
Product summary
- 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
The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.