FDA Medical Device Recalls (openFDA)
Eos Imaging: 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.
- Recall number
- Z-2692-2011
- Recalling firm
- Eos Imaging
- 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.
- Status
- Terminated
- Initiated
- 2011-04-13
- Posted
- 2011-06-28
- Terminated
- 2012-01-18
- Reason
- 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
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K071546","K101398"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3006165260
- Firm city
- Paris
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28