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Terminated

Toshiba Aquilion ONE CT SystemTSX-301 A/2D

FDA Recall Z-2339-2010 · Posted 2010-09-01

Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2009-02-03
Date Terminated2011-09-02
Product Quantity16

Reason for Recall

ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB.

Firm Action

Toshiba America Medical System Inc (TAMS) sent an Urgent: Medical Device Correction dated January 14, 2009 to their consignees. The letter described the issue and provided instructions to test the device to determine if it is an affected device. If the device is affected, contact the Toshiba service representative at 800 521-1968. Consignees were requested to complete and fax a response form to Toshiba.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution: including the states of AL, CA, FL, GA, KY, MA, MD, MT, NV, NY, OH, PA, and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072606AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEMToshiba America Medical Systems, In.C · 2007-10-02

Official Source

View FDA Recall →

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

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