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

FDA device recall Z-0263-2016 · posted 2015-11-10 · Terminated

Recall details

Recalling firm

NeuroLogica Corporation

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.

Action taken

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

Status

Terminated

Product code

IZI

Quantity affected

7 devices

Distribution

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

Date initiated

2015-09-14

Date posted

2015-11-10

Date terminated

2017-01-19

Location

Danvers, MA

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