steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The ster
FDA device recall Z-0580-2014 · posted 2013-12-26 · Terminated
Recall details
- Recalling firm
- EOS Imaging
- Reason for recall
- Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
- Action taken
- EOS imaging issued a safety information letter dated November 29, 2013, to the US customer sites. The letter identifed the affected product, problem and actions to be taken. Users of the sterEOS workstation are asked not to simultaneously open several pairs of images in sterEOS 3D. The letter informed customers that EOS imaging will, at it's own expense, corect all systems affected by means of a software update. An EOS imaging representative will contact affected customers to make an appointment for this update once it is available. Users of the sterEOS workstation are asked not to simultaneously open several pairs of images in sterEOS 3D. For questions call +33 (0) 155 25 6060.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 36 units
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2013-11-29
- Date posted
- 2013-12-26
- Date terminated
- 2015-01-13
- Location
- Paris France, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STEREOS WORKSTATION (K130395) | Eos Imaging, Inc. | 2013-03-11 |