High FDA (Devices)·Z-0263-2016·Announced 2015-11-18

Samsung GM60A-40S Radiographic System Recalled for Drive Control Defect

NeuroLogica Corporation is recalling seven Samsung GM60A-40S radiographic systems because drive behavior may not be properly controlled when moving over conductive floors.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (loss of control) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

NeuroLogica Corporation is recalling seven Samsung GM60A-40S radiographic systems. These devices are intended for use in generating radiographic images of human anatomy. The recall involves specific serial numbers: 50EAM9BG200004X, 50EAM9BG200001A, 50EAM9BG200002P, 50EAM9BG200003D, 50EAM9BG200005N, 50EAM9BG200006E, and 50EAM9BG200007F.

The recall is due to a defect where the system's drive behavior may not be properly controlled when the system moves from a non-conductive floor to a conductive, grounded part. The system can be stopped by releasing the drive handle or pressing the emergency switch, and proper behavior is re-enabled when the system is rebooted.

The affected devices were distributed to the states of North Carolina, Ohio, Massachusetts, and Missouri. Users should contact NeuroLogica Corporation for instructions on how to address the issue.

The recalled product

Product: Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
Manufacturer: NeuroLogica Corporation
Category: Medical Device — Radiographic Equipment
Hazard: loss-of-control
Affected units: 7

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

Serial Numbers: 50EAM9BG200004X
50EAM9BG200001A 50EAM9BG200002P
50EAM9BG200003D
50EAM9BG200005N
50EAM9BG200006E
50EAM9BG200007F

Distribution

Distributed in 4 states:

Same manufacturer · NeuroLogica Corporation

See all →

High
Mobile X-ray systems recalled over bolts that may loosen or fracture
FDA (Devices) · 2025-11-19
High
NeuroLogica GM60A Mobile X-Ray System Anti-Fall Arm Safety Failure Risk
FDA (Devices) · 2024-08-28
High
Samsung GM85 Mobile X-ray System Welding Frame Defect Arm Fall Risk
FDA (Devices) · 2024-02-21
High
OmniTom CT imaging device recalled for wheel loosening and battery contamination
FDA (Devices) · 2023-07-12
High
Samsung GM85 Digital X-ray Imaging System Arm Latch Failure
FDA (Devices) · 2023-04-26

Same hazard · loss of control