平成21年10月30日作成

一般的名称： 自動視野計
販売名　　： 視野検査装置　ＡＳ‐１７

対象製造番号：
10001,10002,10003,10004,10005,10007,10008,10009,10010,10011,10012,10013,10014,10015,10016,10017,
10018,10019,10020,10021,10022,10023,10024,10025,10026,10027,10028,10029,10030,10032,10033,10034,
10035,10036,10037,10038,10039,10040,10041,10042,10044,10045,10046,10048,10049,10050,10051,10052,
10053,10054,10055,10056,10057,10058,10059,10061,10062,10063,10065,10071,10077,10078,10079,10081,
10082,10083,10084,10085,10086,10087,10088,10089,10090,10091,10092,10093,10094,10095,10096,10097,
10098,10099,10100,10101,10102,10103,10104,10105,10106,10107,10108,10109,10110,10111,10112,10113,
10114,10115,10116,10117,10118,10119,10120,10121,10122,10123,10124,10125,10126,10127,10128,10129,
10130,10131,10132,10133,10134,10135,10136,10137,10138,10139,10140,10141,10142,10143,10144,10145,
10146,10147,10148,10149,10150,10151,10152,10153,10154,10155,10156,10157,10158,10159,10160,10161,
10162,10163,10164,10165,10166,10167,10168,10169,10170,10171,10174,10175,10176,10177,10178,10179,
10180,10181,10182,10183,10184,10185,10186,10187,10188,10189,10190,10191,10192,10193,10194,10195,
10196,10197,10198,10199,10200,10201,10202,10203,10204,10205,10206,10208,10209,10210,
20211,20212,20213,20214,20215,20216,20217,20218,20219,20220,20221,20222,20223,20225,20226,20227,
20228,20229,20230,20231,20232,
30233,30234,30235,30236,30237,30238,30239,30240,30241,30242,30243,30244,30245,30246,30247,30248,
30249,30250,30251,30252,30253,30254,30255,30256,30257,30258,30259,30260,30261,30262,30263,30264,
30265,30266,30267,30268,30269,30270,30271,30272,30273,30274,30275,30276,30277,30278,30279,30280,
30281,30282,30283,30284,30285,30286,30287,30288,30289,30290,30291,30292,30293,30294,30296,30297,
30298,30299,30301,30302,30309,
1297100300,1297100303,1297100304,1297100305,1297100306,1297100307,1297100308,1297100310,1297100311,


1297100312,1297100314,1297100315,1297100317,1297100318,1297100319,1297100320,1297100321,1297100322,
1297100323,1297100324,1297100325,1297100326,1297100327,1297100328,1297100331,1297100332,1297100333,


1297100334,1297100335,1297100336,1297100337,1297100338,1297100339,1297100340,1297100342,1297100343,
1297100344,1297100345,1297100346,1297100347,1297100348,1297100349,1297100350,1297100351,1297100352,


1297100353,1297100354,1297100355,1297100356,1297100357,1297100358,1297100359,1297100360,1297100361,
1297100362,1297100363,1297100364,1297100365,1297100366,1297100367,1297100368,1297100369,1297100370,


1297100371,1297100372,1297100373,1297100374,1297100375,1297100376,1297100377,1297100378,1297100379,
1297100380,1297100381,1297100382,1297100383,1297100384,1297100385,1297100386,1297100387,1297100388,


1297100389,1297100390,1297100391,1297100392,1297100393,1297100394,1297100395,1297100396,1297100397,
1297100398,1297100399,1297100400,1297100401,1297100402,1297100403,1297100404,1297100405,1297100406,


1297100407,1297100408,1297100409,1297100410,1297100411,1297100412,1297100413,1297100414,1297100415,
1297100416,1297100417,1297100418,1297100419,1297100420,1297100421,1297100422,1297100423,1297100424,


1297100425,1297100426,1297100427,1297100428,1297100429,1297100430,1297100431,1297100432,1297100433,
1297100434,1297100435,1297100436,1297100437,1297100438,1297100439,1297100440,1297100441,1297100442,


1297100443,1297100444,1297100445,1297100446,1297100447,1297100448,1297100449,1297100450,1297100451,
1297100452,1297100453,1297100454,1297100455,1297100456,1297100457,1297100458,1297100459,1297100460,


1297100461,1297100462,1297100463,1297100464,1297100465,1297100466,1297100467,1297100468,1297100469,
1297100470,1297100471,1297100472,1297100473,1297100474,1297100475,1297100476,1297100477,1297100478,


1297100479,1297100480,1297100481,1297100482,1297100483,1297100484,1297100485,1297100486,1297100487,
1297100488,1297100489,1297100490,1297100491,1297100492,1297100493,1297100494,1297100495,1297100496,


1297100497,1297100498,1297100499,1297100500,1297100501,1297100502,1297100503,1297100504,1297100505,
1297100506,1297100507,1297100508,1297100509,1297100510,1297100511,1297100512,1297100513,1297100514,


1297100515,1297100516,1297100517,1297100518,1297100519,1297100520,1297100521,1297100522,1297100523,
1297100524,1297100525,1297100526,1297100527,1297100528,1297100529,1297100530,1297100531,1297100532,


1297100533,1297100534,1297100536,1297100537,1297100539,1297100540,1297100541,1297100543,1297100544,
1297100545,1297100546,1297100548,1297100549,1297100550,1297100551,1297100552,1297100553,1297100554,


1297100555,1297100556,1297100557,1297100558,1297100560,1297100561,1297100562,1297100576,1297100577,
1297100579,1297100580,1297100582,1297100583,1297100585,1297100587,1297100590,1297100591,1297100612,


1297100616,1297100619,1297100620,1297100621,1297100622,1297100623,1297100625,1297100627,1297100628,
1297100629,1297100631

対象数量：552台
出荷時期：平成８年１０月〜平成２１年９月

製造販売業者の名称　： 興和株式会社　電機光学事業部
製造販売業者の所在地： 東京都中央区日本橋本町３‐４‐１４
許可の種類　　　　　： 第一種医療機器製造販売業
許可番号　　　　　　： 13B1X10038

額当てユニットを固定する部品が折れる事例が発生し、調査を行ったところ、使用想定外ではありますが、この
ユニットを手で掴んで、通常の使用条件とは異なる方向に無理な応力を加えると、固定する部品が破損すること
が分かりましたので、強度を上げた固定部品に交換することにいたしました。

通常の使用では破損する可能性は低く、実際に破壊テストを行いましたが、破損しても鋭利な部分は発生せず、
健康被害が発生する可能性は極めて低いと考えております。
現在まで健康被害の報告はありません。

平成21年10月30日　情報提供開始日

様々な位置に自動的に表示した小さな光点（点）に対する、患者の反応を記録することにより視野測定を行うた
めに使用する。また、様々な位置に手動で表示した小さな光点（点）に対する、患者の反応を記録することによ
り視野測定を行うために使用する。

出荷先は全て把握しておりますので、連絡して改修いたします。

担当者　： 土井慎太郎
連絡先　： 東京都中央区日本橋本町三丁目４番１４号
電話番号： 03-5623-8064
FAX番号 ： 03-5623-8060