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Terminated

Xoran MiniCAT CT Scanner ID ENT00001

FDA Recall Z-0041-2014 · Posted None

Recall StatusTerminated
Product CodeJAK
Date Initiated2009-12-14
Date Terminated2014-09-11
Product Quantity320

Reason for Recall

Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.

Firm Action

The service report in response to this complaint stated that the Head select relay board, chip and fan were replaced. The machine (ENTOOOO I) was subsequently tested. All tests were successful.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution - US nationwide

Official Source

View FDA Recall →

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

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