Z-3188-2018Class II

sterEOS workstation

Name: Z-3188-2018 sterEOS workstation
Creator: EOS Imaging
Published: 2018-08-01
License: https://open.fda.gov/license/

EOS imaging / initiated 2018-08-01 / Terminated / root cause: software

FDA source

EOS Imaging began a recall of sterEOS workstation on 2018-08-01. FDA classified it as Class II and gives the reason as "3D projections may be incorrect when the pair of images used is a secondary capture generated from a series containing more than two images, where one of the images has been manually flipped. Projection errors may lead...". 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-3188-2018
Classification: Class II
Status: Terminated
Initiated: 2018-08-01
Posted: 2018-09-18
Terminated: 2022-08-15
Recalling firm: EOS imaging
Product: sterEOS workstation
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 3D projections may be incorrect when the pair of images used is a secondary capture generated from a series containing more than two images, where one of the images has been manually flipped. Projection errors may lead to errors in calculation of 3D clinical parameters when adjusting the position, size and shape of the 3D objects used. Incorrect clinical parameters can be a contributing factor in incorrect clinical decisions, or sub-optimal surgical interventions.
Root cause tag: software
FDA root cause: Software design
Action: On August 1, 2018, a Field Safety Notice was issued to all impacted customers. Measures to be taken by users: EOS system and sterEOS review workstation users are requested not to apply manual symmetry to an image before saving a 2D secondary capture if more than two images are displayed in the EOS viewer mode or in 2D sterEOS. Users of the 3D sterEOS review workstation are requested to check that 3D projections associated with pelvic parameters match when a 3D image is created from a pair of images belonging to a series of more than two images. INSTRUCTIONS FOR END USERS: 1) Please read the field safety notice. 2) Follow the instructions provided in this field safety notice. 3) Please transfer this notice to whomever needs to be informed within your organization or in any organization to which the sterEOS review workstation may have been transferred. INSTRUCTIONS FOR DISTRIBUTORS: 1) Please read the field safety notice. 2) Please transfer all the documentation relating to the field safety notice to your customers in the field and keep proof of delivery of this documentation. Please regularly submit your customers' response rate to EOS imaging by email ([email protected]). EOS imaging needs this proof to monitor the evolution of corrective measures.
Quantity in commerce: 17 units
Distribution: US nationwide
Product codes and lots: All software versions are impacted

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3188-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3188-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-18

Product code LLZ

K172346Class IIsterEOS WorkstationEos Imaging / cleared 2018-06-19

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)