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Terminated

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 measurement of the retina, retinal nerve fiber layer, macula, and optic disk. The Stratus OCT with Retinal Nerve Fiber Layer and Macula Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including, but not limited to, macular edema, central serous retinopathy, and glaucoma.

FDA Recall Z-2048-2009 · Posted 2009-09-03

Recalling FirmCarl Zeiss Meditec Inc
Recall StatusTerminated
Product CodeHLI
Date Initiated2009-07-31
Date Terminated2010-04-19
Product Quantity244 units

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

Worldwide - US, Austria, UK, Japan, Singapore, Argentina, France, Hong Kong, New Zealand, Canada, Colombia, Germany, Korea, Venezuela, India and China.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033123STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASECarl Zeiss Meditec, Inc. · 2004-04-20K030433STRATUSOCT WITH RNFL NORMATIVE DATABASECarl Zeiss Meditec, Inc. · 2003-05-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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