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.
FDA device recall Z-2692-2011 · posted 2011-06-28 · Terminated
Recall details
- Recalling firm
- Eos Imaging
- 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
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 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.
- Date initiated
- 2011-04-13
- Date posted
- 2011-06-28
- Date terminated
- 2012-01-18
- Location
- Paris, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STEREOS WORKSTATION (K101398) | Biospace Med | 2011-02-04 |
| EOS (K071546) | Biospace Med | 2007-09-18 |