Recall Z-0198-06 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Toshiba American Med Sys Inc
High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system.
| Date | Nov 24, 2005 (initiated Sep 21, 2005) |
| Status | Terminated |
| Reason | It was found during a study, arcing might occur in the transformer of the high voltage generator, XTP-8100G and XTBP-8100G displaying an error message and interrupting fluoroscopy. |
| Root cause | Other |
| Action | Consignees notification that a local TAMS service representative will schedule the implementation of the replacement transformer. |
| Quantity | 30 |
| Distribution | CA, CO, KS, IL, LA, IN, ME, MI, NC, NJ, NY, OH, PA, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.