FDAFDA · Alimentos y medicamentos·N.º oficial Z-0893-2016
Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
Publicado el 2 de marzo de 2016 · Inicio del retiro: 20 de enero de 2016
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Integrated Medical Systems Inc
- Distribuidor
- Distributed US (nationwide) and in Australia.
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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