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Terminated

PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems.

FDA Recall Z-1997-2010 · Posted 2010-07-13

Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeITX
Date Initiated2010-01-05
Date Terminated2012-02-29
Product Quantity27

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 (

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092179APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001Toshiba America Medical Systems, In.C · 2009-07-29K072918MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00Toshibamedical Systems Corporation · 2007-10-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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