Recall Z-2655-2017 ยท KPR System, X-Ray, Stationary
Shimadzu Medical Systems Usa Com
SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals
| Date | May 23, 2017 |
| Status | Terminated |
| Reason | Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. |
| Root cause | Device Design |
| Action | Shimadzu sent an Urgent Voluntary Medical Device Recall Notice to all affected customers. The firm will implement a voluntary recall/field corrective action to add protective parts preventing the x-ray tube assembly from coming into contact with the patient or operator should separation of the tube mounting flange from the tube holding shaft occur. Customers with questions were instructed to call 800-228-1429. |
| Quantity | 1673 units total |
| Distribution | Worldwide Distribution - Nationwide distribution to AK, AR, AZ, CA, CT, FL, IL, IN, KS, LA, MI, MO, NE, NJ, NM, NV, NY,OH, OK, PA, RI, SC, TN, TX, WA, WI, and Hawaii Foreign: Canada and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152294 | FDR Visionary Suite Shimadzu Corporation, Jul 15, 2016 |