PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems.
FDA device recall Z-1997-2010 · posted 2010-07-13 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- 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 (
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 27
- Distribution
- Nationwide
- Date initiated
- 2010-01-05
- Date posted
- 2010-07-13
- Date terminated
- 2012-02-29
- Location
- Tustin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001 (K092179) | Toshiba America Medical Systems, In.C | 2009-07-29 |
| MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00 (K072918) | Toshibamedical Systems Corporation | 2007-10-29 |