Device Recall Pentax

Model #'s: EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970AK, EB-1970K, EB-1970TK and EB-1970UK

Ear, Nose, and Throat Devices

2

No

US Nationwide and Internationally

Video Bronchoscope

Model #'s:ECY-1570 and ECY-1570K

Ear, Nose, and Throat Devices

2

No

US Nationwide and Internationally

Video Cytoscopes

Model #: VNL-1570STK

Ear, Nose, and Throat Devices

2

No

US Nationwide and Internationally

Video Naso pharyngo Laryngoscopes

A110021, A110022, A110023, A110024, A110025, A110026, A110027, A110028, A110029, A110030, A110031, A110032, A110033, A110034, A110035, A110036, A110037, A110038, A110039, A110043, A110046, A110051, A110055, A110056, A110057, A110058, A110059, A110060, A110061, A110062, A110063, A110064, A110065, A110067, A110068, A110070, A110071, A110072, A110073, A110074, A110075, A110076, A110077, A110078, A110079, A110080, A110081, A110082, A110083, A110086, A110087, A110088, A110089, A110090, A110091, A110092, A110095, A110098, A110099, A110100, A110114, A110115, A110116, A110117, A110118, A110121, A110122, A110127, A110128, A110129, A110130, A110131, A110132, A110133, A110134, A110135, A110136, A110137, A110138, A110140, A110142, A110143, A110150, A110152, A110156, A110157, A110158, A110159, A110160, A110162, A110163, A110164, A110165, A110166, A110167, A110168, A110169, A110170, A110173, A110174, A110177, A110178, A110179, A110180, A110182, A110183, A110190, A110191, A110192, A110193, A110194, A110203, A110204, A110206, A110207, A110208, A110209, A110210, A110211, A110213, A110214, A110215, A110216, A110217, A110218, A110229, A110230, A110231, A110232, A110233, A110234, A110235, A110236, A110237, A110243, A110244, A110246, A110247, A110248, A110249, A110250, A110251, A110252, A110258, A110259, A110260, A110268, A110269, A110272, A110273, A110274, A110275, A110276, A110277, A110278, A110279, A110280, A110281, A110283, A110284, A110285, A110287, A110288, A110289, A110290, A110293, A110297, A110301, A110302, A110304, A110305, A110306, A110307, A110308, A110316, A110317, A110318, A110319, A110320, A110321, A110322, A110323, A110324, A110325, A110326, A110327, A110328, A110329, A110331, A110333, A110338, A110339, A110345, A110347, A110352, A110362, A110363, A110385, A110386, A110387, A110388, A110389, A110390, A110391, A110392, A110393, A110399, A110403, A110405, A110406, A110407, A110409, A110410, A110412, A110413, A110415, A110416, A110417, A110418, A110419, A110421, A110422, A110424, A110438, A110439, A110440, A110454, A110462, A110464, A110466, A110468, A110470, A110473, A110474, A110476, A110480, A110483, A110491, A110492, A110495, A110496, A110497, A110498, A110499, A110501, A110502, A110518, A110520, A110521, A110524, A110525, A110527, A110534, A110535, A110538, A110547, A110549, A110550, A110553, A110554, A110555, A110574, A110581, A110582, A110587, A110588, A110589, A110590, A110591, A110593, A110594, A110595, A110596, A110598, A110599, A110600, A110601, A110602, A110607, A110610, A110612, A110614, A110615, A110616, A110617, A110619, A110620, A110621, A110623, A110625, A110626, A110633, A110649, A110651, A110652, A110654, A110665, A110666, A110667, A110668, A110669, A110670, A110671, A110672, A110674, A110675, A110676, A110677, A110678, A110680, A110682, A110683, A110684, A110686, A110692, A110694, A110695, H110699, H110700, H110701, H110703, H110704, H110705, H110706, H110707, H110708, H110709, H110710, H110711, H110712, H110714, H110715, H110716, H110717, H110718, H110719, H110721, H110723, H110729, H110733, H110736, H110737, H110738, H110740, H110749, H110754, H110767, H110773, H110774, H110775, H110779, H110780, H110781, H110782, H110783, H110784, H110786, H110788, H110789, H110790, H110791, H110792, H110793, H110794, H110795, H110796, H110797, H110799, H110800, H110802, H110803, H110805, H110807, H110819, H110822, H110823, H110825, H110826, H110827, H110828, H110830, H110831, H110832, H110834, H110835, H110837, H110838, H110840, H110842, H110844, H110845, H110846, H110849, H110850, H110851, H110852, H110853, H110858, H110859, H110860, H110861, H110862, H110863, H110865, H110866, H110867, H110868, H110869, H110870, H110871, H110872, H110873, H110876, H110877, H110880, H110881, H110882, H110883, H110890, H110891, H110892, H110893, H110894

Gastroenterology-Urology Devices

2

No

Nationwide

Video Duodenoscope

EB-1970UK

Ear, Nose, and Throat Devices

2

No

Nationwide Distribution

Ultrasound Video Bronchoscope || The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.