Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 2660021119710 (new instrument
FDA device recall Z-2048-2009 · posted 2009-09-03 · Terminated
Recall details
- Recalling firm
- Carl Zeiss Meditec Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HLI
- Quantity affected
- 244 units
- Distribution
- Worldwide - US, Austria, UK, Japan, Singapore, Argentina, France, Hong Kong, New Zealand, Canada, Colombia, Germany, Korea, Venezuela, India and China.
- Date initiated
- 2009-07-31
- Date posted
- 2009-09-03
- Date terminated
- 2010-04-19
- Location
- Dublin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE (K033123) | Carl Zeiss Meditec, Inc. | 2004-04-20 |
| STRATUSOCT WITH RNFL NORMATIVE DATABASE (K030433) | Carl Zeiss Meditec, Inc. | 2003-05-01 |