Hitachi Oasis MRI System - C-Spine Coil
Reported: February 1, 2017 Initiated: January 6, 2017 #Z-1096-2017
Product Description
Hitachi Oasis MRI System - C-Spine Coil
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.
Details
- Recalling Firm
- Hitachi Medical Systems America Inc
- Units Affected
- 180 units
- Distribution
- 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.
- Location
- Twinsburg, OH
Frequently Asked Questions
What product was recalled? ▼
Hitachi Oasis MRI System - C-Spine Coil. Recalled by Hitachi Medical Systems America Inc. Units affected: 180 units.
Why was this product recalled? ▼
The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 1, 2017. Severity: Moderate. Recall number: Z-1096-2017.
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