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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

Product Description Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
Recall Number Z-1714-2014
Classification Class II
Code Info Serial Numbers: ULD1412014, UUC13Z2011, A4A113Z2001.
Product Distributed Qty 2
Reason For Recall Toshiba America Medical Systems, Inc. initiated a recall of Toshiba Infinix X-Ray (INFX-8000V/UU), because it has been found that although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, and does not stop.

Event Detail

Event Id 68363
Product Type Devices
Status Ongoing
Recalling Firm Toshiba American Medical Systems Inc
City Tustin
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including CA and IN
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