Z-1391-2018Class II

Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager)...

Name: Z-1391-2018 Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager)...
Creator: NeuroLogica Corporation
Published: 2018-01-12
License: https://open.fda.gov/license/

Samsung HME America, Inc. / initiated 2018-01-12 / Terminated / root cause: design

FDA source

NeuroLogica Corporation began a recall of Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical on 2018-01-12. FDA classified it as Class II and gives the reason as "While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit". 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-1391-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-12
Posted: 2018-04-17
Terminated: 2018-08-14
Recalling firm: Samsung HME America, Inc.
Product: Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.
Root cause tag: design
FDA root cause: Device Design
Action: A field safety notice was sent stating that the manufacturer, without charge, will remedy the defect. The notice stated that field upgrades would be performed by December 31, 2017. The notice provided instructions to end users and to distributors. For further questions, please call (978) 564-8503.
Quantity in commerce: 16 units
Distribution: US Distribution . Only one consignee was shipped 16 units of the affected device.
Product codes and lots: Model Number GMR40. Serial numbers 00001 through 00016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1391-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1391-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17

Product code MQB

K171085Class IIGmr40Neurologica Corporation, A Subsidiary OF / cleared 2017-05-11

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)