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U.S. Department of Health and Human Services

Class 2 Device Recall EOS System

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  Class 2 Device Recall EOS System see related information
Date Initiated by Firm April 13, 2011
Date Posted June 28, 2011
Recall Status1 Terminated 3 on January 18, 2012
Recall Number Z-2692-2011
Recall Event ID 58560
510(K)Number K071546  K101398  
Product Classification System, image processing, radiological - Product Code LLZ
Product Software versions
Eos software versions: 1.2.4, 1.2.5, 1.2.6,1.2.7,1.2.8, 1.2.9,1.2.10, .2.11,1.2.12, 1.2.13, 1.3.2,1.3.3, 1.3.4, 1.4.0, 1.4.1, 1.4.2.

sterEOS software versions: 1.2.3.3788, 1.2.4.4286, 1.3.2.3373, 1.3.3.3671, 1.3.4.3740, 1.3.5.3915, 1.3.6.4272,1.4.1.4813,1.4.2.4850.

EOS system is a digital radiography system used in general radiographic examinations. sterEOS workstation is a medical image review station for acceptance, transfer, display, storage, and digital processing of 2D X-ray images.
Code Information Software versions Eos software versions: 1.2.4, 1.2.5, 1.2.6,1.2.7,1.2.8, 1.2.9,1.2.10, .2.11,1.2.12, 1.2.13, 1.3.2,1.3.3, 1.3.4, 1.4.0, 1.4.1, 1.4.2. sterEOS software versions: 1.2.3.3788, 1.2.4.4286, 1.3.2.3373, 1.3.3.3671, 1.3.4.3740, 1.3.5.3915, 1.3.6.4272,1.4.1.4813,1.4.2.4850. 
Recalling Firm/
Manufacturer		 Eos Imaging
10, Rue Mercoeur
Paris France
Manufacturer Reason
for Recall		 Print true size, print requests from the EOS acquisition station or the sterEOS image review station may, in certain cases, be affected by a different enlargement factor during printing. T
FDA Determined
Cause 2		 Software design
Action EOS imaging sent a "FIELD SAFETY NOTICE" letter dated April 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to wait for the printing queue to empty before sending a second "print true queue" request with different print settings. Customers should then click the button shown on the instruction sheet to view the print queue. EOS imaging will provide a software update to correct all affected systems at no cost to the customers. An EOS representative will contact customers to schedule a time to upgrade the software. Questions can be answered by calling 33 1 55 25 63 90.
Quantity in Commerce 5 EOS Systems, 10 sterEOS workstations
Distribution Worldwide Distribution--USA (nationwide) including the states of CA, IA, MO, VA, and WI, and countries of Canada and Europe.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LLZ and Original Applicant = BIOSPACE MED
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