Z-0263-2016Class II

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

Name: Z-0263-2016 Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy
Creator: NeuroLogica Corporation
Published: 2015-09-14
License: https://open.fda.gov/license/

Samsung HME America, Inc. / initiated 2015-09-14 / Terminated / root cause: design

FDA source

NeuroLogica Corporation began a recall of Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy on 2015-09-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0263-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-14
Posted: 2015-11-10
Terminated: 2017-01-19
Recalling firm: Samsung HME America, Inc.
Product: Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
Product code: IZI System, X-Ray, Angiographic
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.
Root cause tag: design
FDA 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 in commerce: 7 devices
Distribution: Distributed to the states of NC, OH, MA, and MO.
Product codes and lots: Serial Numbers: 50EAM9BG200004X, 50EAM9BG200001A 50EAM9BG200002P, 50EAM9BG200003D, 50EAM9BG200005N, 50EAM9BG200006E, 50EAM9BG200007F

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0263-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0263-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-10

Product code IZI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)