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U.S. Department of Health and Human Services

Class 2 Device Recall Cirrus HDOCT Model 4000 instruments

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  Class 2 Device Recall Cirrus HDOCT Model 4000 instruments see related information
Date Initiated by Firm March 10, 2011
Date Posted May 02, 2011
Recall Status1 Terminated 3 on March 29, 2012
Recall Number Z-2127-2011
Recall Event ID 58313
510(K)Number K083291  
Product Classification Tomography, optical coherence - Product Code OBO
Product Cirrus HD-OCT Model 4000 instruments, new and refurbished, distributed with, or upgraded to, version v 1.0 - 4.5, 5.0.0 or 5.1.0
The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device.
Code Information Software kit part number: 2660021136948 ( v.5.0.0) 2660021140099 (v 5.1.0)(US and OUS) part number 2660021136966 - (v 5.0.0 - China) part number 2660021140811 ( v.5.1.0 - China): Serial numers: 4000-5907 4000-5660 4000-2728 4000-4165 4000-5970 4000-5906 4000-5814 4000-5562 4000-5921 4000-5797 4000-5990 4000-6048 4000-5726 4000-6065 4000-5972 4000-5999 4000-1811 4000-5545 4000-6645 4000-5648 4000-6038 4000-5669 4000-6021 4000-5944 4000-6080 4000-5799 4000-5902 4000-1243 4000-5769 4000-1381 4000-2570 4000-5633 4000-4370 4000-5930 4000-5840 4000-5833 4000-3973 4000-4266 4000-2760 4000-2951 4000-4386 4000-5818 4000-6906 4000-5718 4000-6025 4000-5832 4000-6074 4000-3691 4000-1240 4000-6313 4000-4786 4000-1788 4000-5157 4000-3645 4000-5964 4000-1844 4000-1013 4000-2817 4000-3787 4000-5667 4000-1335 4000-2607 4000-5685 4000-3818 4000-7377 4000-5039 4000-5825 4000-4394 4000-1621 4000-6026 4000-2710 4000-4876 4000-4270 4000-3617 4000-2668 4000-3942 4000-4276 4000-2361 4000-2603 4000-5843 4000-6131 4000-3471 4000-1062 4000-5885 4000-1235 4000-1353 4000-3489 4000-3581 4000-5859 4000-6274 4000-1502 4000-7029 4000-2624 4000-3892 4000-6272 4000-3495 4000-4992 4000-3360 4000-5199 4000-4073 4000-4858 4000-1816 4000-5315 4000-4374 4000-5179 4000-3650 4000-4641 4000-3621 4000-4526 4000-5749 4000-7038 4000-1302 4000-7161 4000-5572 4000-2253 4000-2397 4000-2238 4000-2875 4000-6825 4000-5060 4000-2225 4000-5593 4000-1649 4000-5807 4000-6432 4000-5414 4000-3773 4000-3575 4000-2313 4000-3560 4000-3682 4000-3245 4000-3546 4000-3180 4000-6963 4000-1641 4000-1769 4000-5601 4000-4804 4000-1549 4000-5241 4000-3889 4000-5984 4000-3809 4000-1271 4000-4347 4000-6362 4000-5704 4000-6810 4000-4672 4000-5809 4000-6759 4000-3131 4000-6311 4000-4981 4000-1633 4000-1273 4000-1256 4000-4214 4000-4653 4000-2812 4000-1249 4000-6106 4000-4135 4000-6165 4000-1261 4000-4166 4000-4919 4000-2752 4000-3284 4000-3473 4000-5643 4000-2614 4000-2177 4000-5127 4000-3825 4000-1125 4000-5629 4000-2063 4000-3452 4000-2762 4000-5589 4000-3917 4000-2630 4000-5677 4000-1087 4000-1096 4000-6450 4000-6173 4000-7007 4000-6267 4000-3276 4000-1408 4000-1748 4000-3209 4000-3275 4000-6204 4000-2977 4000-2098 4000-2881 4000-3995 4000-2589 4000-5646 4000-3504 4000-2404 4000-3337 4000-4840 4000-3519 4000-3024 4000-1375 4000-4854 4000-6974 4000-3078 4000-3328 4000-4809 4000-5775 4000-5279 4000-7113 4000-3246 4000-2754 4000-6532 4000-6789 4000-4584 4000-1227 4000-6519 4000-5042 4000-1642 4000-5728 4000-5747 4000-3525 4000-2972 4000-4089 4000-5347 4000-4452 4000-3025 4000-3158 4000-7082 4000-4245 4000-4147 4000-6610 4000-4572 4000-6399 4000-2486 4000-3695 4000-5758 4000-6688 4000-7136 4000-3381 4000-1308 4000-1155 4000-6341 4000-2869 4000-6580 4000-5689 4000-2402 4000-5715 4000-5690 4000-1607 4000-1615 4000-4874 4000-5103 4000-5357 4000-4268 4000-6685 4000-4282 4000-1505 4000-5221 4000-6911 4000-3049 4000-7236 4000-4719 4000-6212 4000-7046 4000-4139 4000-7209 4000-5251 4000-3392 4000-6651 4000-4721 4000-1440 4000-3761 4000-2999 4000-2074 4000-6468 4000-3299 4000-4373 4000-5069 4000-2259 4000-3900 4000-4772 4000-4864 4000-6255 4000-3946 4000-3516 4000-6886 4000-5247 4000-2613 4000-5036 4000-5050 4000-3344 4000-2363 4000-4109 4000-6001 4000-6674 4000-3852 4000-4810 4000-3396 4000-4301 4000-5032 4000-2544 4000-2777 4000-3353 4000-2375 4000-7366 4000-5030 4000-4226 4000-6805 4000-3478 4000-4170 4000-6739 4000-4617 4000-5887 4000-2154 4000-4175 4000-3367 4000-2575 4000-2220 4000-3858 4000-6737 4000-3496 4000-5158 4000-4680 4000-2967 4000-7329 4000-3799 4000-6318 4000-4274 4000-3707 4000-6711 4000-5697 4000-4335 4000-2611 4000-2667 4000-2620 4000-3796 4000-2617 4000-4145 4000-4123 4000-3021 4000-3015 4000-1550 4000-7033 4000-2279 4000-1566 4000-6184 4000-5717 4000-3528 4000-2465 4000-6339 4000-6515 4000-4695 4000-1003 4000-5079 4000-3810 4000-4427 4000-4814 4000-4961 4000-7132 4000-4067 4000-4889 4000-2121 4000-4227 4000-3075 4000-1796 4000-6513 4000-3945 4000-6036 4000-3843 4000-4008 4000-2798 4000-4848 4000-2423 4000-6202 4000-6168 4000-3294 4000-3009 4000-2376 4000-3058 4000-1594 4000-6262 4000-1145 4000-5791 4000-6340 4000-6193 4000-6636 4000-5908 4000-5444 4000-4252 4000-6594 4000-6309 4000-3282 4000-2378 4000-4408 4000-4146 4000-6229 4000-7181 4000-4601 4000-2300 4000-4292 4000-4770 4000-5255 4000-6893 4000-2814 4000-3601 4000-3262 4000-3907 4000-6052 4000-6908 4000-4463 4000-3938 4000-3019 4000-1190 4000-5020 4000-4353 4000-6683 4000-3782 4000-1216 4000-3988 4000-3925 4000-2377 4000-2561 4000-5223 4000-1611 4000-3198 4000-7093 4000-5973 4000-4826 4000-3408 4000-4588 4000-6465 4000-5901 4000-5639 4000-2480 4000-6629 4000-3829 4000-3957 4000-2239 4000-2222 4000-1077 4000-3301 4000-6100 4000-2593 4000-6056 4000-6916 4000-1208 4000-6687 4000-4296 4000-4099 4000-4861 4000-7111 4000-6119 4000-6357 4000-3708 4000-1218 4000-6256 4000-1435 4000-2592 4000-3511 4000-6243 4000-4968 4000-4333 4000-6493 4000-3416 4000-7177 4000-7098 4000-7124 4000-7207 4000-5011 4000-4596 4000-2843 4000-3647 4000-3696 4000-6163 4000-1568 4000-2441 4000-2431 4000-6656 4000-5512 4000-4371 4000-6543 4000-5004 4000-3274 4000-2746 4000-7190 4000-6443 4000-3214 4000-2200 4000-2321 4000-4273 4000-1293 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Recalling Firm/
Manufacturer
Carl Zeiss Meditec Inc
5160 Hacienda Dr
Dublin CA 94568
For Additional Information Contact Judith A. Brimcombe. MA
925-557-4616
Manufacturer Reason
for Recall
A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient
FDA Determined
Cause 2
Software design
Action Carl Zeiss Meditec, Inc. sent an Field Correction Action letter dated March 9, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letters requested acknowledgement of the letter and a response and the fact that a follow up packet with revised software will be sent to all customers with V 5.0.0 or 5.1.0 software. For questions, please call 1-855-853-9461.
Quantity in Commerce 3465 US; 3423 OUS
Distribution Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Boliva, Brazil, Canada, France, Chili, China, Columbia, Denmark, Ecuador,Germany, Great Britain, Greece, Guatemala, Hong Kong, India, Japan, Lebanon, Malaysia, Mexico, New Zealand, Pakistan, Peru, Singapore,South Korea, Spain, Sri Lanka, Taiwan, Uruguay and Venezuela
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 = OBO and Original Applicant = CARL ZEISS MEDITEC INC
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