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U.S. Department of Health and Human Services

Class 3 Device Recall RI Witness Embryology Heated Plate

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  Class 3 Device Recall RI Witness Embryology Heated Plate see related information
Date Initiated by Firm September 05, 2019
Create Date October 02, 2019
Recall Status1 Terminated 3 on September 02, 2021
Recall Number Z-0029-2020
Recall Event ID 83108
510(K)Number K160504  
Product Classification Accessory, assisted reproduction - Product Code MQG
Product Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.
Code Information Serial Numbers: 0006 0051 0097 0146 0192 0244 0292 0354 0420 0487 0617 0672 0732 0783 0007 0052 0098 0147 0193 0245 0293 0356 0421 0489 0618 0673 0733 0784 0008 0053 0100 0148 0194 0246 0294 0357 0424 0490 0619 0674 0734 0785 0009 0054 0101 0149 0195 0247 0297 0358 0426 0491 0622 0675 0735 0786 0010 0055 0102 0150 0196 0248 0298 0359 0428 0492 0628 0676 0736 0787 0011 0056 0103 0151 0197 0249 0299 0360 0429 0493 0630 0677 0738 0788 0012 0057 0104 0152 0198 0250 0300 0361 0430 0494 0631 0678 0739 0789 0013 0058 0105 0153 0199 0251 0302 0362 0431 0495 0632 0679 0740 0790 0014 0060 0106 0154 0200 0252 0303 0364 0432 0496 0633 0680 0741 0791 0015 0061 0107 0155 0201 0253 0304 0366 0433 0497 0634 0681 0742 0792 0016 0062 0108 0156 0203 0254 0306 0367 0434 0498 0635 0682 0743 0793 0017 0063 0109 0157 0204 0255 0307 0368 0435 0499 0636 0683 0744 0794 0018 0064 0110 0158 0205 0256 0308 0369 0438 0501 0637 0684 0745 0795 0019 0065 0111 0159 0206 0257 0309 0370 0440 0502 0638 0685 0747 0796 0020 0066 0112 0160 0207 0258 0311 0371 0441 0503 0639 0686 0748 0797 0021 0067 0113 0161 0208 0259 0312 0372 0442 0504 0641 0687 0749 0798 0022 0068 0114 0162 0209 0260 0313 0373 0443 0505 0642 0688 0752 0799 0023 0069 0115 0163 0210 0261 0314 0374 0444 0508 0643 0689 0753 0800 0024 0070 0116 0164 0211 0263 0315 0375 0445 0509 0644 0690 0754 0801 0025 0071 0117 0165 0212 0264 0316 0378 0446 0511 0645 0691 0755 0802 0026 0072 0118 0166 0213 0265 0317 0380 0447 0512 0646 0703 0756 0803 0027 0073 0119 0167 0214 0266 0318 0381 0449 0513 0647 0704 0757 0028 0074 0120 0168 0215 0267 0319 0383 0450 0514 0648 0705 0758 0029 0075 0121 0169 0216 0268 0320 0386 0453 0515 0649 0707 0759 0030 0076 0122 0170 0217 0269 0321 0388 0455 0516 0650 0708 0760 0031 0077 0123 0171 0218 0270 0322 0389 0456 0520 0651 0709 0761 0032 0078 0124 0173 0219 0271 0323 0390 0457 0528 0653 0710 0762 0033 0079 0125 0174 0220 0272 0324 0393 0458 0530 0654 0712 0763 0034 0080 0126 0175 0221 0273 0325 0394 0459 0600 0655 0713 0764 0035 0081 0127 0176 0224 0275 0326 0395 0460 0601 0656 0714 0765 0036 0082 0128 0177 0225 0276 0327 0396 0462 0602 0657 0716 0766 0037 0083 0129 0178 0227 0277 0328 0399 0463 0603 0658 0717 0767 0038 0084 0130 0179 0228 0278 0329 0400 0464 0604 0659 0718 0768 0039 0085 0131 0180 0229 0279 0330 0403 0466 0605 0660 0719 0769 0040 0086 0132 0181 0230 0280 0331 0405 0468 0606 0661 0720 0770 0041 0087 0133 0182 0231 0281 0332 0406 0475 0607 0662 0721 0771 0042 0088 0134 0183 0232 0282 0333 0408 0476 0608 0663 0722 0774 0043 0089 0136 0184 0235 0283 0334 0411 0477 0609 0664 0723 0775 0044 0090 0137 0185 0237 0284 0335 0412 0479 0610 0665 0724 0776 0045 0091 0140 0186 0238 0285 0336 0413 0480 0611 0666 0725 0777 0046 0092 0141 0187 0239 0286 0337 0414 0481 0612 0667 0726 0778 0047 0093 0142 0188 0240 0287 0342 0415 0482 0613 0668 0727 0779 0048 0094 0143 0189 0241 0288 0348 0416 0483 0614 0669 0728 0780 0049 0095 0144 0190 0242 0290 0349 0417 0484 0615 0670 0729 0781 0050 0096 0145 0191 0243 0291 0350 0419 0485 0616 0671 0730 0782
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Customer Service
203-601-9818
Manufacturer Reason
for Recall		 The touchpad may not work properly after cleaning.
FDA Determined
Cause 2		 Device Design
Action On September 5, 2019, the firm notified customers of the product issue via an Urgent Medical Device Correction letter. Customers who identified affected product at their site were instructed to complete the customer acknowledgement form to arrange for an onsite field service call at CooperSurgical's expense. Otherwise, the issue will be addressed at the customer's next onsite routine service at no expense for the correction. Customers may direct their questions to the firm at 203-601-5200 ext. 3300.
Quantity in Commerce 60
Distribution Worldwide distribution - including US Nationwide in the states of CA, CO, CT, GA, IL, MI, NC, NJ, PA, & WA, and countries of Canada and Denmark.
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 = MQG and Original Applicant = RESEARCH INSTRUMENTS LIMITED
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