FDA Device Recall Z-0005-2009: Toshiba American Medical Systems Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0005-2009.

Recall Res Number

Z-0005-2009

Recalling Firm / Manufacturer

Toshiba American Medical Systems Inc

FEI Number

2020563

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2008-09-29

Date Posted

2009-09-28

Date Terminated

2012-10-04

Product Code

MQB

Event Number

53451

Product Quantity

129

Product Description Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.

Reason for Recall Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation.

Action Details Toshiba issued a letter entitled Important Electronic Product Radiation Warning, September 30, 2008, explaining the issue. The customers were requested to reply to the letter via fax-back form, and a Toshiba service representative would install the corrective action.

Distribution Pattern Nationwide

Code Information / Serial Numbers Software version 3.40 or higher

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Medical Device Recall: Z-0005-2009

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer