Z-2072-2012Class II

EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic...

Name: Z-2072-2012 EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic...
Creator: Eos Imaging Inc
Published: 2012-06-19
License: https://open.fda.gov/license/

EOS imaging / initiated 2012-06-19 / Terminated

FDA source

Eos Imaging Inc began a recall of EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination on 2012-06-19. FDA classified it as Class II and gives the reason as "It was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2072-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-19
Posted: 2012-09-28
Terminated: 2013-09-16
Recalling firm: EOS imaging
Product: EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: It was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode.
FDA root cause: Radiation Control for Health and Safety Act
Action: EOS Imaging notified users by letter on 6/19/12 and that an on site correction would be performed by an EOS Imaging Field Service engineer. EOS indicated in its notification that although this specific defect has not been observed in EOS systems installed in the U.S, they will replace the anode driver boards with new boards equipped with high current capacitors. Similarly, the generator firmware will be upgraded with the software patch that improves the cooling fans' controls. This will be replaced at no charge to the customers, during regularly scheduled preventative maintenance of the user's EOS system. This should be completed by the end of calendar year 2012. Your proposed CAP appears to adequately address the issues you raised in your notification, and is hereby approved. Your proposed customer notification letter as revised, appears to adequately provide instructions with respect to the use of the product pending the correction of the defect and it appears to provide a clear evaluation in nontechnical terms of the potential hazards related to the defect. Your proposed notification letter is hereby approved for distribution to all affected parties. Further questions please call 678-564-5400.
Quantity in commerce: 12 EOS Systems installed in the US
Distribution: Nationwide distribution
Product codes and lots: All associated Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2072-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2072-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-09-28

Product code MQB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)