Z-0726-2018Class II

The GC80 Digital X-ray Imaging System

Name: Z-0726-2018 The GC80 Digital X-ray Imaging System
Creator: NeuroLogica Corporation
Published: 2017-06-22
License: https://open.fda.gov/license/

Samsung HME America, Inc. / initiated 2017-06-22 / Terminated

FDA source

NeuroLogica Corporation began a recall of The GC80 Digital X-ray Imaging System on 2017-06-22. FDA classified it as Class II and gives the reason as "An image was obtained with over exposure during a Thorax examination using the AEC function". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0726-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-22
Posted: 2018-03-02
Terminated: 2018-10-05
Recalling firm: Samsung HME America, Inc.
Product: The GC80 Digital X-ray Imaging System
Product code: KPR System, X-Ray, Stationary
Reason for recall: An image was obtained with over exposure during a Thorax examination using the AEC function.
FDA root cause: Other
Action: On June 22, 2017, Samsung distributed Urgent Field Safety Notices & acknowledgment forms to their customers via email. INSTRUCTIONS FOR END USERS: 1) Please read the Field Safety Notice documentation in detail. 2) Follow the instructions provided in this FSN in relation to any actions which are required of you. 3) Complete the provided acknowledgement form and return to your supplier as soon as possible. Your organizations reply is the evidence we need to monitor the progress of the corrective actions. 4) If required and instructed by this FSN documentation, please undertake all relevant service actions as soon as is practicably possible. INSTRUCTIONS FOR DISTRIBUTORS: 1) Please read the Field Safety Notice documentation in detail. 2) Please review and complete the acknowledgement form provided in this FSN and return to Samsung as soon as possible. Please pass this entire package of FSN documentation onto your customers and ask them to return the completed acknowledgement form. Please forward copies of acknowledgements from end users onto to the email addresses stated above. Samsung require this evidence to monitor the progress of the corrective actions. 4) If required and instructed by this FSN documentation, please undertake all relevant service actions as soon as is practicably possible. Customers with questions were advised to contact their local representative.
Quantity in commerce: 45 units
Distribution: Nationwide US
Product codes and lots: Accession Number 1310459

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0726-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0726-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-02

Product code KPR

K143029Class IIDigital Diagnostic X-ray System (GC80)Samsung Electronics Co., Ltd. / cleared 2015-02-04

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)