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Terminated

Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.

FDA Recall Z-0263-2016 · Posted 2015-11-10

Recalling FirmNeuroLogica Corporation
Recall StatusTerminated
Product CodeIZI
Date Initiated2015-09-14
Date Terminated2017-01-19
Product Quantity7 devices

Reason for Recall

When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. The system can be stopped by releasing the drive handle or by pressing the emergency switch. Proper behavior is re-enabled when the system is rebooted.

Firm Action

An Urgent - Field Safety Notice identifying the affected products, problem involved, root cause, and potential hazards, was sent to customers. In the event the issue occurs, users can release the drive handle or press the emergency switch and the unit will stop. Then, reboot the system. If unintended movements occur, please contact local representative. To correct the issue, service engineers will visit to apply the corrective action. For further information or support concerning this problem, contact local representative.

Root Cause

Device Design

Distribution Pattern

Distributed to the states of NC, OH, MA, and MO.

Official Source

View FDA Recall →

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

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