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Recall Observatory FDA recall evidence

Device product

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

Z-0263-2016

September 14, 2015

Class II

Product summary

Firm
NeuroLogica Corporation
Event
Event 72171
Status
Terminated
Classification
Class II
Quantity
7 devices
Official record key
device-enforcement:Z-0263-2016

Official wording

Reason: 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.

Code information: Serial Numbers: 50EAM9BG200004X, 50EAM9BG200001A 50EAM9BG200002P, 50EAM9BG200003D, 50EAM9BG200005N, 50EAM9BG200006E, 50EAM9BG200007F

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.