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Terminated

Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.

FDA Recall Z-0994-2013 · Posted 2013-03-25

Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeMQB
Date Initiated2012-11-08
Date Terminated2013-03-26
Product Quantity95 units

Reason for Recall

Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed.

Firm Action

In November, 2012, Toshiba America Medical Systems, Inc. sent an Urgent: Medical Device Correction letter to customers. The letter contains a return reply form that is to be faxed to TAMS for retention.

Root Cause

Software design

Distribution Pattern

USA nationwide. No international.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120073INFX-8000V WITHToshibamedical Systems Corporation · 2012-01-26K113052INFINIX-CCIToshiba America Medical Systems, In.C · 2011-11-22K081624INFX-8000F (INFINIX CSI AND INFINIX DPI)Toshiba America Medical Systems, In.C · 2008-06-23K052884MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTORToshiba America Medical Systems, In.C · 2005-10-26

Official Source

View FDA Recall →

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

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