Z-1460-2015Class II

EOS, Digital radiography system used in general radiographic examinations

Name: Z-1460-2015 EOS, Digital radiography system used in general radiographic examinations
Creator: Eos Imaging Inc
Published: 2015-02-17
License: https://open.fda.gov/license/

EOS imaging / initiated 2015-02-17 / Terminated / root cause: manufacturing process

FDA source

Eos Imaging Inc began a recall of EOS, Digital radiography system used in general radiographic examinations on 2015-02-17. FDA classified it as Class II and gives the reason as "When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1460-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-17
Posted: 2015-05-05
Terminated: 2017-05-31
Recalling firm: EOS imaging
Product: EOS, Digital radiography system used in general radiographic examinations.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration.
Root cause tag: manufacturing process
FDA root cause: Radiation Control for Health and Safety Act
Action: Planned Action of EOS Imaging Inc.: 1. Install a new acquisition software version, which will prevent use of the system when improper filter positioning is detected. 2. A customer notification letter which includes a statement that EOS Imaging will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following CDRH approves the CAP subject to the following conditions: 1. Provide documentation to show that all filter positioning subassemblies have been replaced, which you state was implemented to prevent improper filter positioning. 2. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 3. EOS Imaging will implement this CAP by September 1, 2015. For further questions call (678) 564-5400.
Quantity in commerce: 13 units installed in US
Distribution: US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.
Product codes and lots: Model Number - EOS System

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1460-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1460-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-05

Product code MQB

K123740Class IIEosEos Imaging / cleared 2013-02-22

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)