Recall Z-2048-2009 ยท HLI Ophthalmoscope, Ac-Powered
Carl Zeiss Meditec Inc
Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 2660021119710 (new instrument) or 2660022119710 (refurbished instrument), and Stratus 6.0.0 Software Kit, product number 2660021133164. The Stratus OCT is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and
| Date | Sep 3, 2009 (initiated Jul 31, 2009) |
| Status | Terminated |
| Reason | Mis-labeled image. A bug in version 6.0.0 software and 6.0.0 software kit used with Stratus OCT Model 3000 can produce a report that incorrectly labels OD or OS. |
| Root cause | Software design |
| Action | Firm initiated notification to customers on July 2, 2009, by sending a letter via FedEx to US customers, and via e-mail and FedEx to outside US consignees. Customers were informed of the issue and steps needed to correct it. A revised software version will be provided to the customers. Any questions should be directed to Carl Zeiss Meditec, Inc. Customer Care at 1-800-341-6968. |
| Quantity | 244 units |
| Distribution | Worldwide - US, Austria, UK, Japan, Singapore, Argentina, France, Hong Kong, New Zealand, Canada, Colombia, Germany, Korea, Venezuela, India and China. |
| FDA record | Open on fda.gov |