Z-0580-2014Class II

steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images

Name: Z-0580-2014 steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images
Creator: EOS Imaging
Published: 2013-11-29
License: https://open.fda.gov/license/

EOS imaging / initiated 2013-11-29 / Terminated / root cause: software

FDA source

EOS Imaging began a recall of steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for... on 2013-11-29. FDA classified it as Class II and gives the reason as "Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0580-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-29
Posted: 2013-12-26
Terminated: 2015-01-13
Recalling firm: EOS imaging
Product: steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
Root cause tag: software
FDA root cause: Software design
Action: EOS imaging issued a safety information letter dated November 29, 2013, to the US customer sites. The letter identifed the affected product, problem and actions to be taken. Users of the sterEOS workstation are asked not to simultaneously open several pairs of images in sterEOS 3D. The letter informed customers that EOS imaging will, at it's own expense, corect all systems affected by means of a software update. An EOS imaging representative will contact affected customers to make an appointment for this update once it is available. Users of the sterEOS workstation are asked not to simultaneously open several pairs of images in sterEOS 3D. For questions call +33 (0) 155 25 6060.
Quantity in commerce: 36 units
Distribution: USA Nationwide Distribution
Product codes and lots: Software versions: 1.3, 1.4 and 1.5

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0580-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0580-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-26

Product code LLZ

K130395Class IIStereos WorkstationEos Imaging, Inc. / cleared 2013-03-11

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)