Recall Z-0917-2017 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Shimadzu Medical Systems
Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
| Date | Nov 20, 2016 |
| Status | Terminated |
| Reason | Shimadzu Medical Systems is recalling Shimadzu X-ray TV System SONIALVISION due to possibility of oil leaking from the x-ray tube housing under certain conditions. |
| Root cause | Under Investigation by firm |
| Action | An urgent medical device recall notice and a field safety notice dated 11/20/16 was sent to customers to inform them that Shimadzu Corporation has identified a potential issue in the Shimadzu X-ray TV System SONIALVISION G4. Shimadzu informed their customers that they have received a report that oil had leaked from X-ray tube device of SONIALVISION G4 during examination. Customers are informed of the description of the issue, the actions planned by Shimadzu to correct the issue, and the actions that should be taken by the customer. Customers are instructed to contact their local Shimadzu re |
| Quantity | 39 units |
| Distribution | US: TX, NY, SD, PA, MD, OH, IA, IN, MT, IL, FL, SC, OR, CA, AR, GA, CT, NV, PA, NE, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142341 | X-RAY TV SYSTEM SONIALVISION G4 Shimadzu Corp., Mar 6, 2015 |