Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope
Enforcement
- Recall Number
- Z-0901-2016
- Event ID
- 73088
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Integrated Medical Systems Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 2, 2016
- Initiation Date
- January 20, 2016
- Classification Date
- February 25, 2016
- Termination Date
- October 13, 2016
- Address
- 3200 2nd Ave N, N/A, Birmingham, AL, 35222-1212, United States
Description
Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope
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.
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
Distributed US (nationwide) and in Australia.
122 instruments