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Terminated

INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems

FDA Recall Z-0752-2016 · Posted 2016-02-09

Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2015-08-14
Date Terminated2016-05-18
Product Quantity4

Reason for Recall

When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".

Firm Action

Toshiba's planned action to bring into compliance: 1.Affected customers will be notified using the Customer Notification Letter you provided, 2. revised system software will be installed on the systems to prevent this occurrence from happening, 3. the corrections will be made free of charge, and 4. the corrections will be completed by April 4, 2016. For further questions, please call 1- 800 521-1968.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide Distribution to OH and NY

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152696INFX-8000V, V6.20Toshibamedical Systems Corporation · 2016-01-12K120073INFX-8000V WITHToshibamedical Systems Corporation · 2012-01-26

Official Source

View FDA Recall →

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

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