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.
This recall has been terminated (originally issued June 28, 2011).
- Recall Initiated
- April 13, 2011
- Posted
- June 28, 2011
- Terminated
- January 18, 2012
- Recall Number
- Z-2692-2011
- Quantity
- 5 EOS Systems, 10 sterEOS workstations
- Official Source
- View on FDA website ↗
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
Distribution
Worldwide Distribution--USA (nationwide) including the states of CA, IA, MO, VA, and WI, and countries of Canada and Europe.
Lot / Code Info
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.
Root Cause
Software design
Action Taken
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.