Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher, with Normative
FDA device recall Z-1131-2010 · posted 2010-03-15 · Terminated
Recall details
- Recalling firm
- Optovue Inc.
- Reason for recall
- Marketed without proper 510(k)-- No 510(k) clearance for Optovue RTVue Model-RT100 with Software Versions 3.0.x.x and higher which includes the Normative Database.
- Action taken
- The firm is preparing a software "Roll Back" version of software to disable the NDB and other features, ensuring that this version will work properly. A customer notification letter is provided as well as a correction verification form, installation instructions and user manual. If there are any questions, please call 1-866-344-8948.
- Root cause
- Other
- Status
- Terminated
- Product code
- OBO
- Quantity affected
- 1800 units
- Distribution
- Nationwide and Worldwide
- Date initiated
- 2010-01-08
- Date posted
- 2010-03-15
- Date terminated
- 2011-03-24
- Location
- Fremont, CA
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