Class 2 Device Recall Carl Zeisss Meditec, Inc. Stratus OCT

• Date Initiated by Firm: July 31, 2009
• Date Posted: September 03, 2009
• Recall Status: Terminated on April 19, 2010
• Recall Number: Z-2048-2009
• Recall Event ID: 52993
• 510(K)Number: K030433 K033123
• Product Classification: Ophthalmoscope, AC-Powered - Product Code HLI
• 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 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Carl Zeiss Meditec Inc; 5160 Hacienda Dr; Dublin CA 94568
• For Additional Information Contact: 925-557-4353 Ext. 4458
• Manufacturer 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.
• FDA Determined 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 in Commerce: 244 units
• Distribution: Worldwide - US, Austria, UK, Japan, Singapore, Argentina, France, Hong Kong, New Zealand, Canada, Colombia, Germany, Korea, Venezuela, India and China.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HLI and Original Applicant = CARL ZEISS MEDITEC INC