令和 3年12月23日作成
令和 3年12月24日訂正(*)

一般的名称： 眼科用手術台
販売名　　： メプロ

商品名：DR-140　 メプロ
製造番号：AM21J0248,AM21J0247,AM21J0161,AM21J0160,AM21I0657,AM21I0653,AM21I0498,AM21I0421,AM21I0410,
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AM15H0165,AM15H0144,AM15H0091,AM15H0081,AM15H0074,AM15H0043,AM15G0324,AM15G0313,AM15G0259,AM15G0238,
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AM15F0285,AM15F0281,AM15F0272,AM15F0264,AM15F0228,AM15F0220,AM15F0191,AM15F0142,AM15F0100,AM15F0083,
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AM15D0220,AM15D0219,AM15D0218,AM15D0098,AM15D0097,AM15D0096,AM15D0095,AM15D0094,AM15D0093,AM15D0076,
AM15C0442,AM15C0441,AM15C0440,AM15C0439,AM15C0438,AM15C0426,AM15C0400,AM15C0399,AM15C0397,AM15C0396,
AM15C0395,AM15C0308,AM15C0307,AM15C0306,AM15C0305,AM15C0304,AM15C0303,AM15C0302,AM15C0300,AM15C0299,
AM15C0238,AM15C0237,AM15C0236,AM15C0235,AM15C0234,AM15C0233,AM15C0232,AM15C0181,AM15C0180,AM15C0179,
AM15C0178,AM15C0177,AM15C0110,AM15C0109,AM15C0108,AM15C0107,AM15C0106,AM15C0105,AM15C0049,AM15C0048,
AM15C0047,AM15C0046,AM15C0045,AM15C0044,AM15B0384,AM15B0383,AM15B0382,AM15B0381,AM15B0380,AM15B0328,
AM15B0327,AM15B0326,AM15B0325,AM15B0324,AM15B0260,AM15B0259,AM15B0258,AM15B0257,AM15B0256,AM15B0218,
AM15B0217,AM15B0208,AM15B0198,AM15B0188,AM15B0083,AM15B0080,AM15B0076,AM15B0072,AM15B0046,AM15A0317,
AM15A0316,AM15A0314,AM15A0290,AM14L0169,AM14L0168,AM14L0167,AM14L0138
数量：1,176台
出荷時期：2015年1月5日から2021年10月12日

商品名：DR-140J　メプロ４Ｊ
製造番号：AM21J0143,AM21J0090,AM21J0089,AM21J0088,AM21J0079,AM21J0049,AM21I0688,AM21I0672,AM21I0666,
AM21I0665,AM21I0658,AM21I0633,AM21I0517,AM21I0516,AM21I0416,AM21I0415,AM21I0217,AM21I0146,AM21I0145,
AM21I0061,AM21H0401,AM21H0400,AM21H0386,AM21H0321,AM21H0300,AM21H0299,AM21H0254,AM21H0253,AM21H0216,
AM21H0195,AM21H0151,AM21H0150,AM21H0145,AM21H0144,AM21H0077,AM21G0622,AM21G0553,AM21G0513,AM21G0498,
AM21G0496,AM21G0398,AM21G0360,AM21G0355,AM21G0092,AM21F0554,AM21F0512,AM21F0493,AM21F0481,AM21F0389,
AM21F0383,AM21F0371,AM21F0356,AM21F0282,AM21F0219,AM21F0206,AM21F0083,AM21E0619,AM21E0618,AM21E0452,
AM21E0427,AM21E0278,AM21E0269,AM21E0252,AM21E0181,AM21E0180,AM21E0179,AM21E0178,AM21D0559,AM21D0558,
AM21D0508,AM21D0426,AM21D0320,AM21D0242,AM21D0160,AM21D0115,AM21D0114,AM21C0648,AM21C0607,AM21C0606,
AM21C0605,AM21C0597,AM21C0596,AM21C0504,AM21C0492,AM21C0400,AM21C0399,AM21C0390,AM21C0388,AM21C0377,
AM21C0272,AM21B0468,AM21B0463,AM21B0457,AM21B0433,AM21B0407,AM21B0402,AM21B0401,AM21B0372,AM21B0273,
AM21B0272,AM21B0271,AM21B0251,AM21B0250,AM21B0233,AM21B0122,AM21A0685,AM21A0684,AM21A0495,AM21A0404,
AM21A0363,AM20L0507,AM20L0506,AM20L0489,AM20L0434,AM20L0433,AM20L0425,AM20L0208,AM20L0195,AM20L0194,
AM20L0080,AM20L0065,AM20L0064,AM20K0726,AM20K0721,AM20K0720,AM20K0350,AM20K0240,AM20K0237,AM20K0236,
AM20K0232,AM20K0231,AM20J0389,AM20J0388,AM20J0387,AM20J0386,AM20J0383,AM20J0195,AM20J0194,AM20J0146,
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AM20B0390,AM20B0222,AM20B0221,AM20B0212,AM20B0206,AM20B0205,AM20B0204,AM20B0120,AM20B0117,AM20B0105,
AM20B0104,AM20B0054,AM20A0428,AM20A0208,AM20A0207,AM20A0202,AM20A0084,AM20A0083,AM20A0053,AM19L0401,
AM19L0400,AM19L0383,AM19L0359,AM19L0289,AM19L0288,AM19L0203,AM19L0196,AM19L0195,AM19K0351,AM19K0327,
AM19K0326,AM19K0288,AM19K0287,AM19K0240,AM19K0188,AM19K0174,AM19K0173,AM19K0091,AM19K0050,AM19J0253,
AM19J0252,AM19J0234,AM19J0233,AM19J0186,AM19J0185,AM19J0140,AM19J0130,AM19J0110,AM19J0048,AM19I0636,
AM19I0635,AM19I0615,AM19I0539,AM19I0538,AM19I0537,AM19I0536,AM19I0520,AM19I0519,AM19I0518,AM19I0495,
AM19I0361,AM19I0359,AM19I0175,AM19I0174,AM19H0381,AM19H0380,AM19H0378,AM19H0370,AM19H0352,AM19H0310,
AM19H0309,AM19H0294,AM19H0195,AM19H0080,AM19H0079,AM19G0538,AM19G0537,AM19G0525,AM19G0436,AM19G0435,
AM19G0423,AM19G0269,AM19G0111,AM19G0070,AM19F0397,AM19F0396,AM19F0326,AM19F0325,AM19F0291,AM19F0290,
AM19F0254,AM19F0242,AM19F0236,AM19F0235,AM19F0227,AM19F0160,AM19F0159,AM19F0147,AM19F0146,AM19E0343,
AM19E0327,AM19E0326,AM19E0204,AM19E0198,AM19E0197,AM19E0105,AM19E0043,AM19D0594,AM19D0577,AM19D0356,
AM19D0355,AM19D0343,AM19D0210,AM19D0062,AM19D0027,AM19D0026,AM19D0025,AM19C0530,AM19C0529,AM19C0528,
AM19C0527,AM19C0459,AM19C0458,AM19C0452,AM19C0444,AM19C0443,AM19C0408,AM19C0355,AM19C0261,AM19C0126,
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AM18I0071,AM18H0269,AM18H0268,AM18H0214,AM18H0213,AM18H0111,AM18H0101,AM18H0075,AM18H0074,AM18H0068,
AM18H0067,AM18G0312,AM18G0307,AM18G0263,AM18G0218,AM18G0197,AM18G0134,AM18G0124,AM18G0123,AM18G0079,
AM18G0073,AM18F0337,AM18F0300,AM18F0299,AM18F0294,AM18F0293,AM18F0285,AM18F0197,AM18F0196,AM18F0185,
AM18F0184,AM18F0178,AM18F0177,AM18F0145,AM18F0095,AM18F0080,AM18E0436,AM18E0242,AM18E0234,AM18E0223,
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数量：567台
出荷時期：2016年10月28日から2021年10月8日

製造販売業者の名称　： タカラベルモント株式会社　大阪本社
製造販売業者の所在地： 大阪府大阪市中央区東心斎橋2-1-1
許可の種類　　　　　： 第一種医療機器製造販売業
許可番号　　　　　　： 27B1X00042

本製品をご使用頂いておりますお客様より、本製品の「枕が通常スピードより速く動く」という事象が複数件、
当社に寄せられています。
調査したところ、本製品は主電源投入時、油圧制御弁の初期化処理を行なっていますが、下記(1)〜(3)の操作が
連
続的に行われた際に油圧制御弁の状態や操作のタイミング等極めて低い確率で生じる特定の条件を満たした場
合、正常に処理が完了しないことがあることが判明しました。

(1)　本製品を使用する際に主電源スイッチを押下し電源を入れる。
(2)　(1)の操作の途中に、主電源スイッチを戻す。
(3)　再度すぐに主電源スイッチを押下する。

この事象が発生する可能性は、油圧制御弁の状態や操作のタイミング等が特定の条件を満たす必要があるため極
めて低いと考えますが、同様の事象が発生する可能性を完全に否定できないため、出荷済み製品のうち対象とな
る製品について、お客様に情報提供を行なうことで注意喚起を実施し、改善したソフトウェアにアップデートす
る自主改修を実施いたします。

この事象による動作不良が発生した場合、頭部近傍にある器具等（リストレストなど）と患者が意図せず接触す
るおそれがありますが、本製品は医療従事者の監視下で使用され適切な処置が行われることから、重篤な健康被
害に至る可能性はないと考えております。
なお、国内において本事象に関連する不具合・健康被害の報告は受けておりません。

令和3年12月23日　情報提供の開始　12月23日

本機器は眼科手術に使用する電動油圧式の眼科用手術台である。

当該製品の納入先については全て把握していますので、通知の上、納品先医療機関に出向き改修を実施します。
(*)

担当者　： 製品法規制管理部　高瀬 慶和
連絡先　： タカラベルモント株式会社
　　　　　 大阪府大阪市中央区東心斎橋2-1-1
電話番号： 06-6212-5348(*)
FAX番号 ： 06-6212-3697