Z-0901-2016 Class II Terminated
FDA device recall Z-0901-2016 was initiated by Integrated Medical Systems Inc on January 20, 2016 and is designated Class II. 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. The recall status is terminated (terminated October 13, 2016). Affected quantity: 122 instruments.
Recall Details
- Product Type
- Devices
- Report Date
- March 2, 2016
- Initiation Date
- January 20, 2016
- Termination Date
- October 13, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 122 instruments
Product Description
Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope
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.
Distribution Pattern
Distributed US (nationwide) and in Australia.
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