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平成24年8月8日作成 平成25年 9月 9日訂正(*)
一般名及び販売名
一般的名称： （１）移動型診療用照明器 （２）診療用照明器 販売名 ： （１）クロ‐バ‐ ＣＬＯＶＥＲ ＣＳ０３ （２）クロ‐バ‐ シリ‐ズ ＣＬＯＶＥＲ ＳＥＲＩＥＳ
対象ロット、数量及び出荷時期
（１） 数量：１５２台 製造番号： K4023 K4024 K4026 K4027 K4199 K4337 K4371 K4373 K4383 K4391 K4392 K4665 K4367 K4075 K4077 K4201 K4315 K4057 K4058 K4085 K4311 K4322 K4011 K4313 K4324 K4329 K4331 K4365 K4375 K4696 K4697 K4698 K4699 K4700 K4701 K4025 K4078 K4092 K4079 K4195 K4196 K4200 K4203 K4206 K4208 K4235 K4236 K4314 K4317 K4326 K4338 K4342 K4343 K4345 K4347 K4380 K4385 K4658 K4325 K4332 K4197 K4312 K4323 K4007 K4008 K4009 K4010 K4013 K4021 K4076 K4204 K4211 K4659 K4664 K4072 K4073 K4074 K4370 K4393 K4004 K4005 K4012 K4015 K4071 K4086 K4089 K4192 K4202 K4310 K4319 K4333 K4335 K4340 K4368 K4369 K4372 K4374 K4379 K4662 K4663 K4318 K4321 K4327 K4328 K4330 K4366 K4006 K4056 K4205 K4336 K4344 K4378 K4381 K4660 K4014 K4016 K4017 K4018 K4019 K4020 K4022 K4080 K4081 K4082 K4083 K4084 K4087 K4088 K4090 K4091 K4093 K4193 K4194 K4207 K4209 K4210 K4316 K4334 K4339 K4348 K4349 K4350 K4377 K4382 K4384 K4386 K4387 K4388 K4389 K4661 K4666 K4657 出荷時期：平成２２年３月１３日〜平成２２年６月１０日 （２） 数量：８９６台(*) 製造番号： K4744 K5038 K5061 K5062 K5117 K5118 K5119 K5120 K5126 K5150 K5151 K5386 K5407 K5412 K5541 K5545 K5574 K5782 K6405 K6806 K6825 K6837 K6841 K7232 K7402 K7411 K7615 K7627 K7639 K7868 K7873 K7874 K7879 K7991 K8057 K8059 K8068 K8169 K8289 K8292 K8308 K8482 K8485 K8494 K8504 K8506 K8515 K8517 K8648 K9199 K9200 K9238 K9304 K9307 K9316 K9325 K9587 K9595 K9596 K9597 K9757 K9759 K9762 K9774 K9792 K9794 K9948 K9949 K9950 L0127 L0162 L0167 L0178 L0305 L0306 L0496 L0919 L1278 L1279 L1281 L1282 L1283 L1342 K9784 K5777 K5415 K6830 K7989 K8307 K9793 L0159 K7235 K7236 K7237 K7238 K7239 K7403 K7404 K7405 K7406 K7407 K4674 K5381 K5565 K5570 K5578 K5769 K5774 K5786 K6811 K6813 K6821 K6823 K6824 K6840 K7391 K7392 K7393 K7600 K7617 K7619 K7621 K7858 K7864 K7867 K7875 K7878 K8063 K8064 K8065 K8167 K8168 K8281 K8296 K8302 K8303 K8312 K8471 K8472 K8480 K8481 K8631 K8633 K9191 K9194 K9195 K9198 K9201 K9237 K9298 K9301 K9581 K9773 K9799 K9812 K9953 L0138 L0139 L0140 L0141 L0158 L0166 L0184 L0185 L0187 L0309 L0310 L0313 L0314 L0509 L0510 L0910 L1425 L1426 L1427 K4747 K4748 K5043 K5413 K5539 K5577 K6395 K6396 K6815 K6827 K7233 K7234 K7408 K7597 K7631 K8066 K8310 K8479 K8484 K8651 K8656 K8657 K9193 K9240 K9309 K9311 K9312 K9313 K9314 K9315 L0133 L0134 L0135 L0136 L0137 L0161 L0302 L0501 K9804 K4669 K4677 K4736 K4737 K5549 K5564 K6814 K6828 K7613 K7618 K7620 K7623 K7881 K7990 K8067 K8267 K8295 K9245 K9761 L0503 K4667 K4746 K5041 K5042 K5045 K5046 K5221 K5378 K5380 K5384 K5385 K5401 K5414 K5416 K5417 K5418 K5566 K5567 K5576 K6398 K6401 K6406 K6409 K6411 K6414 K6809 K6816 K6817 K6818 K6832 K6836 K7383 K7390 K7409 K7412 K7599 K7607 K7610 K7614 K7624 K7630 K7633 K7636 K7646 K7854 K7855 K7856 K7859 K7860 K7863 K7865 K7866 K7880 K7985 K7986 K7987 K8054 K8070 K8166 K8171 K8264 K8266 K8277 K8279 K8288 K8293 K8309 K8475 K8508 K8511 K8514 K8520 K8632 K8634 K8635 K8637 K8638 K8639 K8640 K8641 K8650 K8654 K8660 K9196 K9197 K9212 K9221 K9222 K9223 K9224 K9225 K9231 K9233 K9234 K9235 K9236 K9296 K9299 K9302 K9317 K9583 K9584 K9585 K9756 K9779 K9783 K9788 K9803 K9810 K9811 K9813 K9814 K9815 L0118 L0119 L0120 L0121 L0142 L0144 L0145 L0146 L0147 L0154 L0160 L0163 L0164 L0165 L0183 L0186 L0312 L0497 L0498 L0506 L0507 L0508 L0733 L0735 L0913 L0914 L0917 L1280 L1340 L1341 L1345 L1343 K7877 K9808 K9211 K7410 K7606 L0179 K9806 K4732 K5050 K5051 K5569 K5771 K6413 K7598 K7616 K8062 K8170 K8294 K8483 K8519 K9232 K9239 L0315 K6807 K9796 K9797 K6408 L0499 L0500 K9798 L0502 L0505 BY00101 L0737 L1093 L1094 L1096 L1275 L1344 K9807 L0918 K4671 K4676 K4733 K4735 K5055 K5056 K5231 K5232 K5402 K5403 K5408 K5555 K5556 K5568 K6404 K6412 K6826 K6838 K6844 K6845 K7388 K7612 K7634 K8191 K8192 K8193 K8194 K8195 K8196 K8197 K8198 K8269 K8270 K8273 K8280 K8283 K8305 K8473 K8474 K8478 K8492 K8498 K8501 K8643 K8649 K9033 K9034 K9035 K9036 K9037 K9038 K9207 K9213 K9214 K9215 K9218 K9229 K9241 K9244 K9306 K9323 K9582 K9590 K9760 K9772 K9786 K9787 K9954 K9955 L0124 L0125 L0149 L0153 L0155 L0156 L0307 K5405 K5772 K6808 K7638 K7857 K8056 K8297 K8642 K9079 K9080 K4740 K5785 K7608 K8299 L0504 K4668 K4670 K4672 K4673 K4681 K4739 K4742 K4745 K4749 K4751 K5035 K5036 K5037 K5039 K5053 K5058 K5228 K5233 K5237 K5382 K5383 K5404 K5406 K5411 K5540 K5542 K5548 K5551 K5562 K5575 K5783 K5784 K5788 K6394 K6397 K6410 K6812 K6819 K6820 K6831 K6843 K7384 K7385 K7389 K7395 K7398 K7399 K7603 K7604 K7605 K7625 K7628 K7632 K7637 K7640 K7853 K7869 K7872 K7992 K7993 K8069 K8072 K8162 K8163 K8164 K8165 K8173 K8174 K8175 K8176 K8177 K8178 K8179 K8180 K8181 K8182 K8183 K8184 K8185 K8186 K8187 K8265 K8268 K8274 K8276 K8282 K8287 K8486 K8499 K8503 K8507 K8513 K8516 K8518 K8644 K8645 K8647 K9192 K9209 K9217 K9219 K9220 K9230 K9243 K9308 K9321 K9580 K9588 K9589 K9592 K9594 K9763 K9768 K9769 K9770 K9771 K9775 K9776 K9789 K9790 K9795 K9800 K9801 K9802 K9809 K9946 L0122 L0126 L0148 L0151 L0152 L0303 L0304 L0317 L0732 L0912 L0915 L1108 L1109 L1110 L1111 L1112 L1113 L1114 L1115 L1116 L1117 L1118 L1119 L1120 L1121 L1122 L1123 L1124 L1125 L1126 L1127 L1273 L1274 L1099 K7401 K8510 K9785 K5543 K5557 K5573 K8060 K8061 K8071 K8659 K4925 K4394 K4678 K4679 K4734 K4738 K4750 K5059 K5063 K5064 K5229 K5230 K5234 K5419 K5544 K5547 K5550 K5553 K5554 K5571 K5778 K5787 K6392 K6402 K6407 K6822 K6829 K6839 K6842 K7386 K7394 K7396 K7397 K7601 K7622 K7861 K7862 K7870 K7871 K7876 K7882 K8271 K8272 K8291 K8298 K8658 K9202 K9206 K9208 K9226 K9227 K9228 K9242 K9303 K9305 K9310 K9319 K9320 K9586 K9591 K9598 K9764 K9765 K9777 K9805 L0123 L0150 L0308 L0736 L0911 L0916 L1090 L1091 L1097 K5572 K9204 K6393 K9781 K4680 K5561 K6835 K8311 K4675 K4741 K4743 K5040 K5044 K5052 K5054 K5060 K5235 K5236 K5379 K5387 K5400 K5409 K5546 K5552 K5558 K5559 K5560 K5770 K5773 K5775 K5776 K5779 K5780 K5781 K6391 K6399 K6400 K6403 K6415 K6810 K6833 K6834 K7230 K7231 K7387 K7400 K7602 K7609 K7611 K7626 K7629 K7635 K7641 K7642 K7643 K7644 K7645 K7994 K8058 K8275 K8278 K8284 K8285 K8286 K8290 K8300 K8301 K8304 K8306 K8313 K8476 K8477 K8491 K8493 K8495 K8496 K8497 K8500 K8502 K8505 K8509 K8512 K8636 K8646 K8652 K8653 K8655 K9203 K9210 K9216 K9300 K9318 K9322 K9324 K9593 K9599 K9758 K9766 K9767 K9778 K9780 K9782 K9791 K9947 K9951 K9952 L0128 L0129 L0130 L0132 L0311 L0316 L0734 L1092 L1095 L1100 L1277 L0180 L0181 L0182 K8055 K8053 L1276 K5563 K9297 L0131 L0644 L0645 L0646 L0647 L0648 L0649 L0650 L0651 L0652 L0653 L0654 K5057 K9205 L0157 L1089 出荷時期：平成２２年６月２５日〜平成２４年６月２０日
製造販売業者等名称
製造販売業者の名称 ： 山田医療照明株式会社 製造販売業者の所在地： 東京都千代田区西神田２‐３‐１６ 許可の種類 ： 第二種医療機器製造販売業 許可番号 ： １３Ｂ２Ｘ００３７５
改修理由
クロ‐バ‐ シリ‐ズ ＣＬＯＶＥＲ ＳＥＲＩＥＳにおいて、スタンド型の移動型照明器の脚部に衝撃が 加わることにより、ひび割れが発生する事例がありました。この衝撃の程度は弊社として想定以上の衝撃力で した。ひび割れが進行すると照明器が転倒する恐れがあります。より安全な製品をご使用して頂くために材質 を改良した脚部と取り換える自主改修を行います。クロ‐バ‐ ＣＬＯＶＥＲ ＣＳ０３の脚部は、クロ‐バ‐ シリ‐ズと同様の脚部を使用しているため、自主改修を行います。
危惧される具体的な健康被害
過度の衝撃により脚部のひび割れが拡大した場合、5本足の一部が破損しバランスが崩れますが、脚部が床面に 接地する事で傾斜した状態で留まると考えられます。改修対象の機器は診療用の照明器であり、医師、看護師等 の医療従事者がいる環境で使用され、仮にポールが倒れたとしても即座に対応可能であるため、重篤な健康被害 発生の可能性は無いと考えます。なお、これまでに当不具合による健康被害はありません。
改修開始年月日
平成２４年８月１日 この日は情報提供の開始日です。
効能・効果又は用途等
診療室等で利用する移動型の照明器。
その他
納入した販売先はすべて把握しておりますので、文書にて通知のうえ自主改修を実施いたします。
担当者及び連絡先
担当者 ： 岡 和彦 連絡先 ： 埼玉工場 品質保証部 電話番号： ０４８‐９９４‐２６１３ FAX番号 ： ０４８‐９９４‐２６２３