Recall Z-0263-2016— NeuroLogica Corporation

Name: FDA recall Z-0263-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-14

Class II · Terminated

Class II FDA medical device recall by NeuroLogica Corporation, initiated 2015-09-14, terminated 2017-01-19. It names 2 FDA 510(k) clearances: K150097, K142492. Product: Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.. 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..

Recalling firm: NeuroLogica Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-09-14
Terminated: 2017-01-19
Firm location: Danvers, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K150097 — GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd.·cleared 2015-02-19
K142492 — GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd.·cleared 2014-12-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.