Z-1096-2017 Class II Terminated
FDA device recall Z-1096-2017 was initiated by Hitachi Medical Systems America Inc on January 6, 2017 and is designated Class II. 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. The recall status is terminated (terminated November 8, 2018). Affected quantity: 180 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 1, 2017
- Initiation Date
- January 6, 2017
- Termination Date
- November 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 180 units
Product Description
Reason for Recall
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.