PlainRecordsFDA · Medical device recall
Cirrus HD-OCT Model 400 instruments… and 1 more product
- Date posted by the FDA
- May 2, 2011
- Status
- Terminated
- Filed by
- Carl Zeiss Meditec Inc
- Reason
- 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
- Distribution pattern
- 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
2 products in this recall
Cirrus HD-OCT Model 400 instruments…
- Product
- Cirrus HD-OCT Model 400 instruments; new and refurbished, with or upgraded to, version 4.6 or 5.1.0 software. The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device.
- Quantity
- 3465 US, 3423 OUS
- Codes and lots
- Software kit part number: 2660021140099 (US and OUS): part number 2660021140811 - China: Serial numbers: 400-10225 400-10220 400-10216 400-10281 400-10256 400-10212 400-10258 400-10278 400-10211 400-10262 400-10676 400-10269 400-10139 400-10261 400-10223 400-10286 400-10253 400-10296 400-10277 400-10082 400-10299 400-10266 400-10188 400-10319 400-10297 400-10591 400-10798 400-10493 400-10750 400-10733 400-10355 400-10058 400-10549 400-10617 400-10071 400-10115 400-10130 400-10457 400-10273 400-10003 400-10646 400-10486 400-11037 400-10275 400-10072 400-10772 400-10516 400-10218 400-10082 400-10316 400-10000 400-10001 400-10002 400-10004 400-10005 400-10006 400-10007 400-10008 400-10009 400-10011 400-10012 400-10014 400-10016 400-10019 400-10021 400-10024 400-10027 400-10028 400-10029 400-10030 400-10035 400-10037 400-10043 400-10044 400-10045 400-10046 400-10048 400-10051 400-10052 400-10054 400-10055 400-10059 400-10061 400-10064 400-10066 400-10069 400-10073 400-10074 400-10076 400-10081 400-10083 400-10084 400-10085 400-10087 400-10088 400-10089 400-10090 400-10092 400-10095 400-10096 400-10099 400-10104 400-10105 400-10108 400-10109 400-10110 400-10111 400-10112 400-10113 400-10116 400-10117 400-10118 400-10119 400-10121 400-10123 400-10124 400-10125 400-10126 400-10127 400-10128 400-10129 400-10131 400-10132 400-10133 400-10134 400-10135 400-10136 400-10137 400-10138 400-10140 400-10141 400-10142 400-10144 400-10145 400-10146 400-10148 400-10149 400-10152 400-10156 400-10158 400-10159 400-10161 400-10162 400-10163 400-10164 400-10165 400-10166 400-10167 400-10168 400-10169 400-10170 400-10171 400-10172 400-10173 400-10175 400-10177 400-10179 400-10180 400-10181 400-10182 400-10183 400-10184 400-10185 400-10186 400-10187 400-10190 400-10191 400-10192 400-10194 400-10195 400-10196 400-10197 400-10199 400-10202 400-10234 400-10237 400-10239 400-10240 400-10241 400-10242 400-10243 400-10244 400-10245 400-10246 400-10248 400-10252 400-10263 400-10272 400-10274 400-10276 400-10279 400-10283 400-10294 400-10298 400-10307 400-10326 400-10328 400-10329 400-10334 400-10336 400-10337 400-10338 400-10340 400-10341 400-10343 400-10354 400-10357 400-10360 400-10361 400-10366 400-10372 400-10373 400-10374 400-10375 400-10377 400-10378 400-10382 400-10383 400-10384 400-10385 400-10386 400-10388 400-10389 400-10391 400-10393 400-10394 400-10395 400-10397 400-10400 400-10403 400-10404 400-10420 400-10425 400-10426 400-10433 400-10434 400-10445 400-10447 400-10449 400-10451 400-10452 400-10453 400-10454 400-10458 400-10459 400-10460 400-10467 400-10471 400-10474 400-10475 400-10477 400-10478 400-10482 400-10483 400-10484 400-10485 400-10487 400-10488 400-10489 400-10490 400-10491 400-10492 400-10494 400-10495 400-10496 400-10497 400-10498 400-10499 400-10501 400-10502 400-10504 400-10505 400-10506 400-10507 400-10508 400-10509 400-10510 400-10511 400-10512 400-10513 400-10514 400-10515 400-10518 400-10521 400-10522 400-10524 400-10525 400-10526 400-10528…
- Recall started
- March 10, 2011
- Device type
- Tomography, Optical Coherence
- Root cause (FDA)
- Software design
- What the company told customers
- 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.
- Recall number
- Z-2126-2011
Cirrus HD-OCT Model 4000 instruments…
- 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.
- Quantity
- 3465 US; 3423 OUS
- Codes and lots
- 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…
- Recall started
- March 10, 2011
- Device type
- Tomography, Optical Coherence
- Root cause (FDA)
- Software design
- What the company told customers
- 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.
- Recall number
- Z-2127-2011
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-2126-2011, Z-2127-2011. The agency record governs; check it and the company before acting.