FDA Medical Device Recalls (openFDA)
NeuroLogica Corporation: Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
- Recall number
- Z-0263-2016
- Recalling firm
- NeuroLogica Corporation
- Product
- Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
- Status
- Terminated
- Initiated
- 2015-09-14
- Posted
- 2015-11-10
- Terminated
- 2017-01-19
- 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.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 7 devices
- Distribution
- Distributed to the states of NC, OH, MA, and MO.
- Lot, serial or model codes
- Serial Numbers: 50EAM9BG200004X, 50EAM9BG200001A 50EAM9BG200002P, 50EAM9BG200003D, 50EAM9BG200005N, 50EAM9BG200006E, 50EAM9BG200007F
- 510(k) numbers
- ["K142492","K150097"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 3004938766
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28