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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73088

22 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 20, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Integrated Medical Systems Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

22 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 22

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

Z-0889-2016
Recall number
Z-0889-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
190 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

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

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 2 of 22

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

Z-0890-2016
Recall number
Z-0890-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
275 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

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

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 3 of 22

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

Z-0891-2016
Recall number
Z-0891-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
232 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers: 2601800,2807942,2104002,2807968,2003519,2003522,2003506,2003533,2003517,2807849, 2807869,2106004,2001560,2602147,2806411,2900360,2001561,2602228,2602229,2309559, 2309556,2602230,2805615,2103724,2103717,2002975,2805586,2806264,2806591,2705038, 2908746,2808043,2704335,2705017,2002983,2106012,2105987,2106009,2106019,2002580, 2002571,2104510,2002603,2900105,2001677,2105162,2909901,2703303,2909972,2601007, 2601084,2104893,2704419,2806374,2806356,2104903,2908799,2601095,2807327,2640009, 2702843,2207664,2207660,2702782,2106428,2806318,2908674,2702730,2704143,2703560, 2106031,2908845,2908846,2908841,2908838,2908852,2908837,2908840,2908843,2106106, 2601525,2807589,2808233,2309810,2805782,2909109,2601535,2104776,2104781,2806163, 2908908,2103829,2104924,2002427,2909718,2002323,2703941,2601588,2601200,2600263, 2309366,2602033,2602034,2900148,2106202,2003379,2000851,2003280,2106797,2003653, 2106800,2807548,2106791,2909657,2003008,2003228,2003232,2106134,2808000,2900241, 2900656,2000774,2106423,2003189,2106410,2309513,2900683,2106413,2807888,2309493, 2106264,2106409,2106422,2107166,2909809,2107149,2808271,2702536,2702344,2704544, 2704568,2704587,2703158,2104281,2703144,2602024,2002832,2805717,2002833,2600272, 2704020,2001762,2207531,2900586,2003128,2208594,2002620,2309683,2001688,2104750, 2104891,2309573,2000881,2309635,2001645,2001650,2106010,2104981,2104993,2104937, 2104890,2900413,2703200,2601190,2309828,2909966,2601218,2001712,2601205,2806343, 2704399,2704716,2105584,2105562,2105559,2104847,2601672,2601642,2602223,2808051, 2703078,2002521,2601938,2601866,2908548,2908499,2105744,2909315,2105988,2106017, 2309497,2309262,2104662,2806423,2105002,2105542,2001423,2309783,2703663,2703654, 2001547,2600215,2001708,2001468,2001514,2001519,2309845,2001311,2309105,2208046, 2208058,2806987,2704187,2208651,2309470,2003116,2003086,2003104,2208215,2001850, 2805888,2309542

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 4 of 22

Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope

Z-0892-2016
Recall number
Z-0892-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
111 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers: 2203925,2001221,2205721,2102757,2102758,2000420,2419219,2001053,2001248,2001285, 2103701,2307844,2408213,2419900,2419587,2419391,2307188,2408135,2408138,2205035, 2205321,2306154,2103419,2000710,2408319,2103515,2204385,2204384,2510491,2419538, 2001154,2103711,2101909,2306353,2103416,2000041,2103345,2408554,2408663,2307057, 2103617,2419115,2306153,2205297,2205019,2306510,2419520,2000431,2408693,2205441, 2419920,2204907,2102886,2102877,2306758,2306495,2000590,2510424,2205820,2307047, 2307014,2307030,2307052,2307066,2306132,2204209,2204663,2204110,2419379,2205371, 2205380,2205384,2408566,2204782,2103708,2101363,2419549,2001300,2103162,2103161, 2510637,2419320,2204264,2204882,2408764,2408487,2419319,2510526,2204325,2419745, 2204606,2103269,2102524,2419255,2419198,2204551,2000906,2307366,2307304,2103274, 2510151,2419258,2102792,2307251,2102786,2307350,2419462,2407416,2306959,2306800, 2307470

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 5 of 22

Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope

Z-0893-2016
Recall number
Z-0893-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
180 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers: 2102433,2102439,2102434,2002026,2002023,2000101,2000567,2001703,2317892,2001252, 2103738,2206336,2001183,2317780,2317782,2001658,2002113,2002108,2001058,2205716, 2103267,2206418,2104707,2104698,2000541,2001445,2000352,2104483,2104215,2001040, 2104379,2104209,2103329,2103015,2104488,2102974,2206175,2001272,2001664,2001241, 2317793,2105371,2001462,2418248,2418397,2105032,2418202,2001127,2001130,2206216, 2104357,2104490,2103447,2205654,2103446,2103440,2205664,2001504,2001507,2104514, 2001451,2104498,2104528,2104474,2001880,2001877,2104733,2104747,2104736,2104746, 2206304,2001661,2001630,2001629,2001626,2001641,2104502,2206298,2104780,2104768, 2104772,2317557,2001884,2317515,2104773,2105392,2205478,2105396,2205463,2205479, 2102775,2217033,2217029,2217036,2104347,2002170,2206318,2317401,2317975,2103228, 2317752,2216831,2317699,2317693,2317691,2103700,2103695,2104487,2104491,2103098, 2103009,2103295,2104653,2317589,2104541,2002004,2002001,2104533,2001862,2103606, 2103935,2104349,2000395,2103657,2317957,2000953,2206569,2103744,2217195,2002120, 2317577,2104489,2103049,2317690,2103060,2317683,2317684,2103375,2000500,2216960, 2000389,2000634,2105256,2105255,2105150,2317905,2317875,2103770,2103557,2103574, 2216820,2217126,2217122,2206257,2206237,2206196,2206239,2206200,2206049,2001713, 2206052,2206240,2001536,2317519,2216863,2102463,2102459,2102464,2102474,2001783, 2001781,2001788,2001747,2001770,2001778,2001756,2001755,2001785,2105103,2001731

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 6 of 22

Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope

Z-0894-2016
Recall number
Z-0894-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
185 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers: 2501321,2603572,2603751,2707414,2500011,2705546,2604232,2603079,2500780,2808458, 2001720,2002054,2001724,2001723,2501905,2809593,2705417,2500916,2808421,2809413, 2705911,2203846,2808998,2501295,2809000,2705264,2603152,2809444,2706645,2102694, 2203503,2809061,2705453,2706361,2102880,2002142,2500236,2705566,2705242,2500869, 2501511,2603466,2706515,2706908,2706905,2706442,2001193,2501087,2501807,2705697, 2705333,2900664,2501186,2800014,2707065,2705978,2501786,2002139,2002083,2809935, 2809951,2707769,2304352,2707593,2304332,2001807,2808518,2602866,2602846,2706687, 2001864,2808509,2705957,2706072,2705888,2602226,2102504,2501901,2501941,2900354, 2501928,2203680,2500463,2203472,2707126,2603744,2707886,2901047,2603180,2604176, 2707760,2502049,2602102,2706079,2706071,2603287,2602732,2602730,2900859,2705386, 2808456,2705662,2809750,2705605,2705589,2808232,2706404,2500529,2602714,2501738, 2706823,2809590,2604997,2604999,2604989,2808704,2808713,2604264,2706028,2800064, 2808452,2500660,2501776,2808455,2501961,2501854,2809540,2501472,2602442,2603316, 2808333,2707097,2706919,2707574,2501001,2706156,2605035,2501890,2603001,2603053, 2706604,2707840,2501962,2605156,2808499,2304527,2603134,2604932,2102468,2500067, 2501704,2501595,2603135,2705891,2807973,2705461,2603530,2707882,2706068,2807964, 2706013,2705465,2707101,2705475,2707892,2500032,2602610,2501680,2707346,2707374, 2707382,2500458,2500653,2808341,2808894,2603444,2001317,2602502,2604160,2500576, 2706920,2808353,2705694,2705593,2900826,2900764,2604623,2901059

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 7 of 22

Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope

Z-0895-2016
Recall number
Z-0895-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
21 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers: 2000023,2110370,2211004,2210975,2110666,2110583,2411739,22109S9,2311220,2812668, 2311177,2110498,2411568,2110745,2110711,2000181,2211040,2812506,2110504, 2311372,2012921

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 8 of 22

Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope

Z-0896-2016
Recall number
Z-0896-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
82 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers: 2807123,2706168,2704697,2704696,2706205,2603823,2500832,2806683,2706253, 2706256,2704313,2704314,2008421,2602202,2602873,2806818,2704323,2603826, 2806676,2807264,2603013,2602S15,2501708,2806563,2501622,2602650,2501251, 2704932,2501637,2705315,2208812,2603725,2806595,2601980,2500885,2603935, 2705615,2705705,2705305,2500522,2907865,2705498,2603941,2807163,2807143, 2501819,2704886,2501553,2501744,2501768,2603178,2603044,2704755,2501372, 2807593,2705425,2208838,2208833,2706176,2008309,2704655,2705847,2706206, 2603321,2705005,2501169,2704832,2704839,2602446,2806333,2705983,2500287, 2601941,2501912,2604229,2501770,2806741,2806744,2603057,2704336,2806592, 2500217

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 9 of 22

Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope

Z-0897-2016
Recall number
Z-0897-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
5 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers: 2123053,2337714,2338700,2337727,2112612

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 10 of 22

Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope

Z-0898-2016
Recall number
Z-0898-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
26 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers: 2000158, 2203109,2000413,2101113,2304140,2203874,2405424,2203295,2203853, 2517622,2101047,2102290,2102302,2102305,2102303,2203697,2102317,2102297, 2202898,2203059,2203471,2304922,2202617,2416261,2102141,2101633

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 11 of 22

Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope

Z-0899-2016
Recall number
Z-0899-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
9 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers: 2813102,2914792,2711389,2711291,2812266,2812356,2802476,2600371,2914632, 2914333

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 12 of 22

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

Z-0900-2016
Recall number
Z-0900-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
12 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

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

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 13 of 22

Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope

Z-0901-2016
Recall number
Z-0901-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
122 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers:2707306,2705876,2807674,2706579,2009538,2706717,2604531,2706710,2501499, 2808113,2705777,2705730,2707016,2808779,2808777,2707125,2603799,2603795, 2603779,2603825,2604265,2807420,2604568,2501361,2500180,2602289,2909274, 2808355,2808217,2808957,2808020,2602290,2707346,2707406,2808556,2807468, 2603295,2604460,2705711,2009462,2602564,2501493,2808528,2500150,2603952, 2603243,2807523,2500982,2500983,2706852,2706892,2009425,2500420,2501392, 2603200,2807685,2501550,2501315,2706332,2604191,2604217,2706407,2603757, 2603028,2603031,2501324,2300253,2300252,2603975,2704883,2603976,2807640, 2808342,2707351,2602872,2808599,2706811,2707210,2500216,2501543,2808299, 2808816,2100010,2807695,2009697,2500686,2604024,2705191,2808911,2808139, 2602993,2705168,2500369,2500602,2501796,2705522,2009502,2808909,2808836, 2601829,2601832,2807758,2707152,2808449,2501699,2601820,2501213,2200069, 2808356,2704854,2704864,2603401,2704735,2603647,2705203,2808490,2501463, 2602027,2705832,2501166,2603137,2603106

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 14 of 22

Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope

Z-0902-2016
Recall number
Z-0902-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
43 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers: 2427253,2528563,2315445,2314847,2212887,2315826,2000027,2314864,2315955, 2213834,2212872,2315727,2315729,2213866,2416648,2427952,2416195,2314929, 2111326,2416125,2213186,2111744,2315611,2213344,2314241,2427731,2427747, 2314885,2314876,2314596,2010689,2314038,2315864,2010526,2315138,2315140, 2315540,2111669,2212839,2212640,2427816,2314895,2427562

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 15 of 22

Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope

Z-0903-2016
Recall number
Z-0903-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
9 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers: 2127866,2712435,2914674,2026893,2916216,2813792,2228261,2711888,2600329

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 16 of 22

Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope

Z-0904-2016
Recall number
Z-0904-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
54 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers: 2407409,2407584,2306291,2204284,2305898,2406901,2306874,2000549,2203971, 2407393,2203790,2000405,2306456,2102668,2203672,2406988,2102128,2103100, 2103035,2204108,2204527,2000464,2204116,2102323,2417865,2102954,2519556, 2418512,2306371,2305350,2407684,2519174,2519207,2519210,2102734,2205217, 2001322,2418634,2406987,2418156,2305446,2204190,2204202,2103307,2101785, 2518969,2519343,2102896,2203946,2001430,2305568,2102316,2305870,2204258

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 17 of 22

Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope

Z-0905-2016
Recall number
Z-0905-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
16 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers: 2201503,2000062,2000105,2100621,2301997,2100999,2201555,2302025,2000061, 2201491,2000039,2100930,2402518,2302084,2100852,2101121

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 18 of 22

Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope

Z-0906-2016
Recall number
Z-0906-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
4 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers: 2600297,2601232,2600397,2013906

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 19 of 22

Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope

Z-0907-2016
Recall number
Z-0907-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
3 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers: 2700328,2912416,2811408

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 20 of 22

Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope

Z-0908-2016
Recall number
Z-0908-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
1 instrument

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Number 2303917

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 21 of 22

Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope

Z-0909-2016
Recall number
Z-0909-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
2 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Numbers: 2913081,2600279

Distribution pattern

Distributed US (nationwide) and in Australia.

device · product 22 of 22

Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope

Z-0910-2016
Recall number
Z-0910-2016
Initiated
January 20, 2016
Classification
Class II
Status
Terminated
Quantity
1 instrument

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Code information

Serial Number 240T024

Distribution pattern

Distributed US (nationwide) and in Australia.