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U.S. Department of Health and Human Services

Class 2 Device Recall sterEOS workstation

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 Class 2 Device Recall sterEOS workstationsee related information
Date Initiated by FirmAugust 01, 2018
Create DateSeptember 18, 2018
Recall Status1 Terminated 3 on August 15, 2022
Recall NumberZ-3188-2018
Recall Event ID 80938
510(K)NumberK172346 
Product Classification System, image processing, radiological - Product Code LLZ
ProductsterEOS workstation
Code Information All software versions are impacted
Recalling Firm/
Manufacturer		 EOS Imaging
4 Ieme Etage
10 Rue Mercoeur
Paris France
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 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 (regulatory@eos-imaging.com). EOS imaging needs this proof to monitor the evolution of corrective measures.
Quantity in Commerce17 units
DistributionUS nationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LLZ
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