Device Recall Olympus

Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10.

Not Classified

No

Nationwide Distribution.

Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. || Mobile X-ray System.

Serial numbers 622483, 622523, 622553, 622566, 622568, 622569, 622573, 622576, 622614, 622615, 622616, 622617, 622618, 622619, 622620, 622632, 622643, 622644, 622645, 622646, 622647, 622654, 622655, 622656, 622657, 622658, 622664, 622666, 622667, 622687, 622688, 622693, 622704, 622705, 622706, 622710, 622711, 622712, 622718, 622719, 622720, 622722, 622723, 622750, 622753, 622764, 622766, 622767, 622769, 622771, 622773, 622775, 622777, 622778, 622785, 622789, 622795, 622797, 622798, 622801, 622806, 623624, 623626, 623629, 623637, 623638, 623639, 623641, 623661, 623669, 623671, 623672, 623673, 623677, 623687, 623688, 623705, 623709, 623713, 623719, 623720, 623722, 623723, 623729, 623730, 623731, 623735, 623736, 623737, 623738, 623739, 623740, 623741, 623742, 623743, 623747, 623749, 623750, 623751, 623752, 623776, 623778, 623784, 623786, 623787, 623788, 623799, 623800, 623801, 623802, 624004, 624005, 624006, 624008, 624011, 624012, 624016, 624017, 624018, 624019, 624024, 624028, 624030, 624041, 624042, 624046, 624054, 624055, 624056, 624057, 624064, 624066, 624070, 624071, 624073, 624076, 624077, 624080, 624082, 624089, 624099, 624100, 624101, 624104, 624107, 624109, 624110, 624112, 624114, 624117, 624119, 624121, 624151, 624158, 624162, 624167, 624170, 624618, 624622, 624643, 624678, 624679, 624682, 624683, 624720, 622539, 622540, 622570, 622572, 623734, 623748, 624739, and 624741.

Obstetrical and Gynecological Devices

2

No

US Nationwide Distribution including these states: NE, IL, FL, TX, OH, PA, IN, CA, NY, AL, ND, GA, AK, MI, WA, MS, NJ, IA, AZ, and RI.

Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

Serial Numbers: 2801185,2801376,2700216,2903833,2903851,2700830,2801154,2700481,2700049, 2025259,2802540,2700325

Gastroenterology-Urology Devices

2

No

Distributed US (nationwide) and in Australia.

Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope

Serial Numbers: 2005030,2800270,2007268,2802306,2802294,2108696,2801707,2006928,2201349,2904573, 2108936,2006513,2107568,2801235,2800468,2200301,2006896,2802237,2802245,2109496, 2109225,2006520,2200358,2200372,2200370,2200350,2200356,2200364,2200351,2200345, 2005915,2109239,2109237,2904265,2108385,2100007,2904378,2801427,2200930,2107811, 2700057,2004864,2004924,2800273,2109999,2100088,2301603,2107560,2200701,2200648, 2904362,2802353,2802234,2801828,2801792,2903393,2903491,2109241,2109087,2109090, 2201179,2109261,2109234,2802808,2801887,2801892,2007452,2801960,2006598,2903718, 2007242,2007253,2903751,2006554,2006560,2802465,2007275,2004893,2802541,2903876, 2903913,2200971,2700124,2904046,2904425,2007142,2802500,2904240,2109319,2800517, 2802466,2802455,2200168,2006418,2200172,2006479,2108689,2201411,2201402,2005274, 2005123,2005141,2201410,2201389,2903348,2800505,2006883,2801725,2200481,2903648, 2903632,2108188,2108969,2109228,2109233,2802031,2802017,2802028,2802016,2802029, 2108350,2108320,2801583,2903806,2904150,2007033,2903029,2802758,2802794,2802793, 2005497,2005545,2700076,2903964,2903965,2903969,2201427,2100108,2007401,2802654, 2005642,2802394,2903060,2903059,2903756,2200703,2200988,2201112,2903499,2904701, 2802756,2005665,2800338,2108452,2100110,2201023,2301893,2301911,2904358,2904345, 2904344,2904356,2904336,2802111,2005706,2005255,2200750,2200766,2200880,2200769, 2200774,2005599,2802920,2006131,2006639,2006641,2006642,2006638,2006640,2006632, 2006628,2006635,2006634,2903927,2005006,2904212,2903346,2802333,2904016,2903343

Gastroenterology-Urology Devices

2

No

Distributed US (nationwide) and in Australia.

Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope

Serial Numbers: 2003035,2704738,2704724,2809007,2808939,2105965,2808765,2004365,2004669,2902353, 2902347,2902342,2004663,2602122,2105267,2601317,2806231,2805648,2808714,2807053, 2807205,2705548,2806959,2704571,2704560,2704611,2705574,2805740,2004809,2703149, 2601037,2901878,2702879,2702870,2703000,2704441,2902854,2003990,2003988,2705078, 2004004,2702967,2808478,2809057,2601256,2601255,2808955,2808944,2807181,2809202, 2206863,2900222,2900226,2900745,2901670,2900229,2003063,2902820,2002897,2600226, 2602014,2003460,2900362,2900112,2806936,2003147,270517S,2704934,2909893,2909872, 2909863,2901323,2806640,2704259,2106188,2106273,2601745,2704573,2003712,2807584, 2807557,2807713,2106293,2106290,2106303,2106300,2807679,2704771,2704770,2704792, 2704800,2602187,2704885,2808319,2602175,2808317,2602190,2702863,2808937,2809103, 2901274,2002984,2002916,2901389,2901374,2601611,2805999,2004421,2704766,2703778, 2705367,2795393,2805917,2805916,2809093,2902295,2004720,2902215,2809055,2004871, 2705449,2809016,2809050,2808936,2808938,2805816,2809044,2900211,2901687,2601179, 2602413,2704897,2705037,2808546,2808581,2808537,2808530,2004462,2004461,2004458, 2004457,2004452,2900338,2806650,2900337,2704236,2704202,2806696,2902604,2703089, 2601468,2004949,2702732,2602089,2808410,2808402,2808413,2808391,2808412,2808415, 2808405,2808379,2807126,2705106,2805727,2702820,2705110,2702954,2704316,2103301, 2901080,2901329,2901326,2900094,2807461,2807463,2600468,2600432,2600183,2003532, 2602342,2901759,2901798,2901789,2901786,2004023,2004047,2601355,2206691,2807571, 2601721,2900252,2808516,2809385,2809049,2809068,2809056,2809060,2806692,2806772, 2702822,2807586,2703753,2106008,2902452,2704036,2601438,2703138,2601515,2703127, 2703134,2105807,2806871,2806863,2003144,2902409,2806880,2809409,2703670,2900905, 2900885,2900901,2900907,2900902,2900892,2902465,2105610,2600472,2602482,2004043, 2909906,2808548,2602237,2901669,2900507,2705345,2703372,2600645,2003099,2807855, 2806888,2807784,2807852,2704075,2900761,2806646,2900595,2809208,2902564,2600735, 2003799,2601893,2602481,2003728,2003726,2900894,2808085,2808064,2808060,2900874, 2003167,2105243,2909945,2601918,2809264,2909796,2909798,2004189,2704407,2901872, 2808189,2808188,2600417

Gastroenterology-Urology Devices

2

No

Distributed US (nationwide) and in Australia.

Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope