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Terminated

X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D

FDA Recall Z-0494-05 · Posted None

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product Coderad
Date Initiated2004-09-07
Date Terminated2012-02-10
Product Quantity494

Reason for Recall

Non-compliance with Radiation Standards. Incorrect display of the radiographic time, due to software anomaly.

Firm Action

Firm sent recall letters to customers and will be following up with field corrections which will be made on-site by the firm's own employees.

Root Cause

Other

Distribution Pattern

Nationwide.

Official Source

View FDA Recall →

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

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