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 measurement of the retina, retinal nerve fiber layer, macula, and optic disk. The Stratus OCT with Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Carl Zeiss Meditec Inc
Lot Codes / Batch Numbers
Instrument serial numbers 3000-1366, 3000-1691, 3000-3058, 3000-3222, 3000-3660, 3000-3959, 3000-4641, 3000-4696, 3000-4802, 3000-5269, 3000-5304, 3000-5457, 3000-6070, 3000-6174, 3000-6258, 3000-6468, 3000-6517, 3000-6770, 3000-6894, 3000-7118, 3000-7157, 3000-7752, 3000-7834, 3000-7847, 3000-8226, 3000-8491, 3000-8534, 3000-8920, 3000-9441, 3000-9469, 3000-9530, 3000-9705, 3000-9791, 3000-9974, 3001-0156, 3001-0235, 3001-0324, 3001-0820, 3001-0842, 3001-0851, 3001-0854, 3001-1002, 3001-1028, 3001-1044, 3001-1046, 3001-1048, 3001-1049, 3001-1052, 3001-1054, 3001-1055, 3001-1056, 3001-1057, 3001-1067, 3001-1069, 3001-1070, 3001-1071, 3001-1072, 3001-1075, 3001-1076, 3001-1077, 3001-1078, 3001-1079, 3001-1083, 3001-1084, 3001-1085, 3001-1086, 3001-1088, 3001-1090, 3001-1093, 3001-1095, 3001-1096, 3001-1098, 3001-1116, 3001-1117, 3001-1119, 3001-1120, 3002-10267, 3002-6731, and 3002-7265. Software ugprade license numbers MSR-10000, MSR-10002, MSR-10003, MSR-10005, MSR-10008, MSR-10009, MSR-10010, MSR-10011, MSR-10012, MSR-10013, MSR-10014, MSR-10015, MSR-10016, MSR-10017, MSR-10019, MSR-10020, MSR-10021, MSR-10022, MSR-10023, MSR-10024, MSR-10025, MSR-10026, MSR-10028, MSR-10029, MSR-10030, MSR-10031, MSR-10032, MSR-10033, MSR-10035, MSR-10036, MSR-10037, MSR-10039, MSR-10040, MSR-10041, MSR-10045, MSR-10048, MSR-10049, MSR-10057, MSR-10058, MSR-10060, MSR-10065, MSR-10066, MSR-10067, MSR-10072, MSR-10073, MSR-10074, MSR-10075, MSR-10076, MSR-10077, MSR-10078, MSR-10079, MSR-10080, MSR-10081, MSR-10082, MSR-10083, MSR-10084, MSR-10086, MSR-10087, MSR-10088, MSR-10089, MSR-10090, MSR-10091, MSR-10092, MSR-10094, MSR-10096, MSR-10097, MSR-10099, MSR-10100, MSR-10101, MSR-10102, MSR-10103, MSR-10106, MSR-10108, MSR-10110, MSR-10111, MSR-10116, MSR-10120, MSR-10124, MSR-10125, MSR-10126, MSR-10127, MSR-10128, MSR-10129, MSR-10130, MSR-10131, MSR-10132, MSR-10133, MSR-10134, MSR-10135, MSR-10136, MSR-10137, MSR-10138, MSR-10139, MSR-10140, MSR-10141, MSR-10142, MSR-10143, MSR-10144, MSR-10148, MSR-10149, MSR-10150, MSR-10151, MSR-10157, MSR-10158, MSR-10160, MSR-10162, MSR-10168, MSR-10184, MSR-10198, and MSR-10199. Review software license numbers RVW6RMJM-00101, RVW6RMJM-00111, RVW6RMJM-00121, RVW6RMJM-00131, RVW6RMJM-00141, RVW6RMJM-00151, RVW6RMJM-00161, RVW6RMJM-00171, RVW6RMJM-00181, RVW6RMJM-00201, RVW6RMJM-00211, RVW6RMJM-00221, RVW6RMJM-00231, RVW6RMJM-00231, RVW6RMJM-00241, RVW6RMJM-00251, RVW6RMJM-00291, RVW6RMJM-00301, RVW6RMJM-00311, RVW6RMJM-00321, RVW6RMJM-00331, RVW6RMJM-00341, RVW6RMJM-00361, RVW6RMJM-00371, RVW6RMJM-00381, RVW6RMJM-00391, RVW6RMJM-00401, RVW6RMJM-00411, RVW6RMJM-00421, RVW6RMJM-00431, RVW6RMJM-00441, RVW6RMJM-00451, RVW6RMJM-00471, RVW6RMJM-00481, RVW6RMJM-00491, RVW6RMJM-00501, RVW6RMJM-00521, RVW6RMJM-00531, RVW6RMJM-00541, RVW6RMJM-00551, RVW6RMJM-00561, RVW6RMJM-00571, RVW6RMJM-00581, RVW6RMJM-00591, RVW6RMJM-00601, RVW6RMJM-00611, RVW6RMJM-00631, RVW6RMJM-00641, RVW6RMJM-00651, RVW6RMJM-00661, RVW6RMJM-00671, RVW6RMJM-00681, RVW6RMJM-00691, RVW6RMJM-00741, RVW6RMJM-00761, RVW6RMJM-00771, and RVW6RMJM-01341. Code RDCM1-00111.
Products Sold
Instrument serial numbers 3000-1366, 3000-1691, 3000-3058, 3000-3222, 3000-3660, 3000-3959, 3000-4641, 3000-4696, 3000-4802, 3000-5269, 3000-5304, 3000-5457, 3000-6070, 3000-6174, 3000-6258, 3000-6468, 3000-6517, 3000-6770, 3000-6894, 3000-7118, 3000-7157, 3000-7752, 3000-7834, 3000-7847, 3000-8226, 3000-8491, 3000-8534, 3000-8920, 3000-9441, 3000-9469, 3000-9530, 3000-9705, 3000-9791, 3000-9974, 3001-0156, 3001-0235, 3001-0324, 3001-0820, 3001-0842, 3001-0851, 3001-0854, 3001-1002, 3001-1028, 3001-1044, 3001-1046, 3001-1048, 3001-1049, 3001-1052, 3001-1054, 3001-1055, 3001-1056, 3001-1057, 3001-1067, 3001-1069, 3001-1070, 3001-1071, 3001-1072, 3001-1075, 3001-1076, 3001-1077, 3001-1078, 3001-1079, 3001-1083, 3001-1084, 3001-1085, 3001-1086, 3001-1088, 3001-1090, 3001-1093, 3001-1095, 3001-1096, 3001-1098, 3001-1116, 3001-1117, 3001-1119, 3001-1120, 3002-10267, 3002-6731, and 3002-7265. Software ugprade license numbers MSR-10000, MSR-10002, MSR-10003, MSR-10005, MSR-10008, MSR-10009, MSR-10010, MSR-10011, MSR-10012, MSR-10013, MSR-10014, MSR-10015, MSR-10016, MSR-10017, MSR-10019, MSR-10020, MSR-10021, MSR-10022, MSR-10023, MSR-10024, MSR-10025, MSR-10026, MSR-10028, MSR-10029, MSR-10030, MSR-10031, MSR-10032, MSR-10033, MSR-10035, MSR-10036, MSR-10037, MSR-10039, MSR-10040, MSR-10041, MSR-10045, MSR-10048, MSR-10049, MSR-10057, MSR-10058, MSR-10060, MSR-10065, MSR-10066, MSR-10067, MSR-10072, MSR-10073, MSR-10074, MSR-10075, MSR-10076, MSR-10077, MSR-10078, MSR-10079, MSR-10080, MSR-10081, MSR-10082, MSR-10083, MSR-10084, MSR-10086, MSR-10087, MSR-10088, MSR-10089, MSR-10090, MSR-10091, MSR-10092, MSR-10094, MSR-10096, MSR-10097, MSR-10099, MSR-10100, MSR-10101, MSR-10102, MSR-10103, MSR-10106, MSR-10108, MSR-10110, MSR-10111, MSR-10116, MSR-10120, MSR-10124, MSR-10125, MSR-10126, MSR-10127, MSR-10128, MSR-10129, MSR-10130, MSR-10131, MSR-10132, MSR-10133, MSR-10134, MSR-10135, MSR-10136, MSR-10137, MSR-10138, MSR-10139, MSR-10140, MSR-10141, MSR-10142, MSR-10143, MSR-10144, MSR-10148, MSR-10149, MSR-10150, MSR-10151, MSR-10157, MSR-10158, MSR-10160, MSR-10162, MSR-10168, MSR-10184, MSR-10198, and MSR-10199. Review software license numbers RVW6RMJM-00101, RVW6RMJM-00111, RVW6RMJM-00121, RVW6RMJM-00131, RVW6RMJM-00141, RVW6RMJM-00151, RVW6RMJM-00161, RVW6RMJM-00171, RVW6RMJM-00181, RVW6RMJM-00201, RVW6RMJM-00211, RVW6RMJM-00221, RVW6RMJM-00231, RVW6RMJM-00231, RVW6RMJM-00241, RVW6RMJM-00251, RVW6RMJM-00291, RVW6RMJM-00301, RVW6RMJM-00311, RVW6RMJM-00321, RVW6RMJM-00331, RVW6RMJM-00341, RVW6RMJM-00361, RVW6RMJM-00371, RVW6RMJM-00381, RVW6RMJM-00391, RVW6RMJM-00401, RVW6RMJM-00411, RVW6RMJM-00421, RVW6RMJM-00431, RVW6RMJM-00441, RVW6RMJM-00451, RVW6RMJM-00471, RVW6RMJM-00481, RVW6RMJM-00491, RVW6RMJM-00501, RVW6RMJM-00521, RVW6RMJM-00531, RVW6RMJM-00541, RVW6RMJM-00551, RVW6RMJM-00561, RVW6RMJM-00571, RVW6RMJM-00581, RVW6RMJM-00591, RVW6RMJM-00601, RVW6RMJM-00611, RVW6RMJM-00631, RVW6RMJM-00641, RVW6RMJM-00651, RVW6RMJM-00661, RVW6RMJM-00671, RVW6RMJM-00681, RVW6RMJM-00691, RVW6RMJM-00741, RVW6RMJM-00761, RVW6RMJM-00771, and RVW6RMJM-01341. Code RDCM1-00111.
Carl Zeiss Meditec Inc is recalling Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 266002111 due to 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 labe. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026