Recall Z-1997-2010 ยท ITX Transducer, Ultrasonic, Diagnostic
Toshiba American Medical Systems Inc
PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems.
| Date | Jul 13, 2010 (initiated Jan 5, 2010) |
| Status | Terminated |
| Reason | Toshiba America Medical Systems is initiating a field correction on the PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems due to an incorrect sweep direction setting. Images acquired using the endo-cavitary transducer PVT-681MV and cross-sectional images created from these volume images are reversed horizontally on the Aplio XG (SSA-790A) and the Xario XG ( |
| Root cause | Other |
| Action | Toshiba America Medical Systems (TAMS) will issue notification to consignees via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS as proof of notification. matter. Questions regarding this letter are directed to the firm at (800) 421-1968 or to your local Toshiba representative. |
| Quantity | 27 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |