Samsung GM60A-40S recallZ-0263-2016 · NeuroLogica Corporation · initiated Sep 14, 2015
Class II Terminated All recalls posted in November 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from NeuroLogica Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0263-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 14, 2015
- Posted by the FDA
- Nov 10, 2015
- Recalling firm
- NeuroLogica Corporation
- Quantity
- 7 devices
- Product code
- IZI
- FDA submissions
- K142492, K150097
- Distribution
- Distributed to the states of NC, OH, MA, and MO.
Product description
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
Code information (models, lots, serial numbers)
Serial Numbers: 50EAM9BG200004X, 50EAM9BG200001A 50EAM9BG200002P, 50EAM9BG200003D, 50EAM9BG200005N, 50EAM9BG200006E, 50EAM9BG200007F
Other devices under the same FDA submission
2 devices cleared under K142492, K150097 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA GM60A-40SSamsung Electronics Co., Ltd. · System, X-Ray, Mobile1 recall0 reports
- NA GM60A-32SSamsung Electronics Co., Ltd. · Solid State X-Ray Imager (Flat Panel/Digital Imager)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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