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Terminated

Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E; Electrostatic x-ray imaging system

FDA Recall Z-1177-2010 · Posted 2010-03-22

Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeMQB
Date Initiated2009-05-22
Date Terminated2012-03-21
Product Quantity20

Reason for Recall

Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging system due to a software bug that results in a loss of image.

Firm Action

An Urgent - Medical Device Correction letter was sent to customers. The letter described the issue, the corrective action, and the avoidance. Toshiba America Medical Systems informed customers that software was being prepared to address the issue and planned to send representatives to each customer affected by the field correction to provide a software upgrade to the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging system. Customers were to complete the attached customer reply form. Questions were to be directed to Aaron Ybarra, X-ray Product Manager at 800-421-1968, ext. 2492.

Root Cause

Component design/selection

Distribution Pattern

Nationwide Distribution -- Including states of PA, VA, OH, TN, LA, IL, CA, MT, AZ, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K073165DRAD-3000E, RADREX-IToshiba America Medical Systems, In.C · 2007-11-16

Official Source

View FDA Recall →

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

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