Verathon, Inc.

Serial numbers:  CC012000, CC012001, CC012002, CC012003, CC012004, CC012005, CC012006, CC012007, CC012008, CC012009, CC012010, CC012011, CC012012, CC012013, CC012014, CC012016, CC012017, CC012018, CC012019, CC012020, CC012021, CC012022, CC012024, CC012026, CC012027, CC012028, CC012029, CC012030, CC012031, CC012032, CC012033, CC012034, CC012035, CC012036, CC012037, CC012038, CC012039, CC012040, CC012041, CC012042, CC012044, CC012045, CC012046, CC012049, CC012050, CC012052, CC012054, CC012055, CC012056, CC012057, CC012058, CC012059, CC012060, CC012061, CC012062, CC012063, CC012064, CC012065, CC012066, CC012067, CC012068, CC012069, CC012070, CC012071, CC012072, CC012075, CC012076, CC012080, CC012083, and CC012084.

Radiology Devices

2

No

Worldwide Distribution: U.S. nationwide including states AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, LA, MA, MD, MI, MN, MO, ND, NY, OH, PA, SC, TN, TX, UT, WI, and Washington DC, and the countries of Australia, Canada, France, South Korea, Taiwan, The Netherlands, and United Kingdom.

The label (which is affixed to ScanPoint Communications Cradle) states: "...VERATHON ScanPoint Docking Station...Part No. 0570-0168...Bothell, WA USA..."

Serial numbers range for GVL3: 0574-0007/ MD105000 to MD112387; Serial numbers range for GVL4: 0574-0001/ LG105000 to LG112758; Serial numbers range for GVL5: 0574-0030/ XL105000 to XL111798.

Anesthesiology Devices

1

No

Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NM, NV, NJ, NY, OK, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and countries of: Argentina, Australia, Canada, China, France, Germany, Indonesia, Japan, The Netherlands, Pakistan, Panama, Peru, Philippines, Singapore, South Korea, Taiwan, Thailand, United Kingdom, and Venezuela.

The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. || The affected GVL and Part numbers are GVL 3  0574-0007, GVL 4  0574-0001, and GVL 5  0574-0030. || The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.

Serial numbers:   B5001000, B5001003, B5001004, B5001007, B5001011, B5001016, B5001017, B5001018, B5001020, B5001021, B5001022, B5001023, B5001024, B5001025, B5001026, B5001027, B5001032, B5001062, B5001069, B5001070, B5001074, B5001075, B5001076, B5001077, B5001078, B5001079, B5001080, B5001081, B5001088, B5001090, B5001091, B5001092, B5001093, B5001095, B5001098, B5001099, B5001101, B5001102, B5001103, B5001104, B5001105, B5001106, B5001107, B5001108, B5001109, B5001110, B5001111, B5001113, B5001114, B5001115, B5001116, B5001117, B5001118, B5001119, B5001120, B5001121, B5001122, B5001123, B5001124, B5001125, B5001126, B5001127, B5001128, B5001129, B5001132, B5001138, B5001139, B5001140, B5001141, B5001142, B5001143, B5001144, B5001147, B5001148, B5001149, B5001150, B5001152, B5001156, B5001157, B5001158, B5001159, B5001160, B5001162, B5001164, B5001166, B5001170, B5001171, B5001172, B5001173, B5001174, B5001175, B5001176, B5001177, B5001179, B5001180, B5001181, B5001182, B5001184, B5001186, B5001187, B5001188, B5001189, B5001190, B5001191, B5001192, B5001194, B5001195, B5001197, B5001198, B5001199, B5001200, B5001201, B5001202, B5001203, B5001204, B5001206, B5001208, B5001209, B5001210, B5001211, B5001212, B5001215, B5001217, B5001218, B5001219, B5001220, B5001221, B5001222, B5001223, B5001224, B5001225, B5001226, B5001228, B5001230, B5001231, B5001233, B5001234, B5001235, B5001236, B5001237, B5001238, B5001239, B5001240, B5001241, B5001245, B5001246, B5001247, B5001249, B5001250, B5001251, B5001252, B5001253, B5001254, B5001256, B5001264, B5001265, B5001266, B5001267, B5001268, B5001269, B5001271, B5001273, B5001274, B5001275, B5001276, B5001277, B5001278, B5001279, B5001280, B5001282, B5001283, B5001285, B5001286, B5001288, B5001289, B5001290, B5001291, B5001292, B5001293, B5001294, B5001295, B5001296, B5001297, B5001298, B5001299, B5001300, B5001302, B5001309, B5001310, B5001313, B5001314, B5001315, B5001316, B5001317, B5001318, B5001319, B5001320, B5001321, B5001322, B5001323, B5001327, B5001328, B5001329, B5001330, B5001331, B5001332, B5001333, B5001334, B5001335, B5001336, B5001338, B5001339, B5001340, B5001341, B5001342, B5001343, B5001344, B5001345, B5001346, B5001347, B5001348, B5001349, B5001350, B5001351, B5001352, B5001353, B5001354, B5001355, B5001356, B5001357, B5001358, B5001359, B5001360, B5001363, B5001364, B5001365, B5001366, B5001367, B5001368, B5001369, B5001370, B5001371, B5001372, B5001373, B5001374, B5001375, B5001376, B5001377, B5001378, B5001380, B5001383, B5001384, B5001385, B5001386, B5001387, B5001388, B5001390, B5001391, B5001392, and B5001393.

Radiology Devices

2

No

Worldwide Distribution - USA and the countries of Australia, Canada, China, Colombia, European Union, United Kingdom, Saudi Arabia, and Singapore.

BladderScan BVM 9500 || The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.

Serial numbers:   A7001001, A7001005, A7001040, A7001041, A7001042, A7001043, A7001044, A7001045, A7001046, A7001047, A7001048, A7001049, A7001050, A7001051, A7001052, A7001053, A7001054, A7001055, A7001056, A7001057, A7001062, A7001065, A7001066, A7001067, A7001069, A7001071, A7001089, A7001090, A7001091, A7001092, A7001093, A7001094, A7001095, A7001096, A7001097, A7001098, A7001099, A7001100, A7001101, A7001102, A7001103, A7001106, A7001107, A7001108, A7001109, A7001110, A7001111, A7001112, A7001113, A7001114, A7001115, A7001116, A7001117, A7001118, A7001119, A7001120, A7001121, A7001122, A7001123, A7001124, A7001125, A7001127, A7001128, A7001129, A7001130, A7001131, A7001132, A7001133, A7001134, A7001135, A7001136, A7001138, and A7001139.

Radiology Devices

2

No

Worldwide Distribution - USA and the countries of Australia, Canada, China, Colombia, European Union, United Kingdom, Saudi Arabia, and Singapore.

AortaScan AMI 9700 || The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements

Serial numbers:   B6001061, B6001062, B6001063, B6001064, B6001065, B6001066, B6001067, B6001068, B6001069, B6001070, B6001071, B6001072, B6001073, B6001074, B6001075, B6001076, B6001077, B6001078, B6001079, B6001080, B6001081, B6001082, B6001083, B6001084, B6001085, B6001086, B6001088, B6001090, B6001092, B6001093, B6001097, B6001098, B6001103, B6001104, B6001107, B6001108, B6001109, B6001110, B6001111, B6001112, B6001113, B6001134, B6001164, B6001166, B6001167, B6001168, B6001169, B6001170, B6001172, B6001173, B6001174, B6001175, B6001176, B6001177, B6001178, B6001179, B6001181, B6001184, B6001185, B6001186, B6001187, B6001188, B6001189, B6001190, B6001191, B6001192, B6001198, B6001199, B6001200, B6001201, B6001202, B6001203, B6001204, B6001205, B6001206, B6001207, B6001208, B6001209, B6001211, B6001212, B6001213, B6001215, B6001216, B6001217, B6001218, B6001219, B6001220, B6001221, B6001223, B6001224, B6001225, B6001232, B6001233, B6001234, B6001239, B6001240, B6001242, B6001243, B6001244, B6001245, B6001251, B6001253, B6001254, B6001255, B6001256, B6001257, B6001258, B6001259, B6001260, B6001261, B6001263, B6001265, B6001267, B6001269, B6001270, B6001271, B6001272, B6001273, B6001277, B6001278, B6001279, B6001280, B6001281, B6001282, B6001283, B6001284, B6001285, B6001286, B6001287, B6001288, B6001289, B6001290, B6001291, B6001292, B6001293, B6001294, B6001295, B6001296, B6001297, B6001298, B6001299, B6001300, B6001301, B6001302, B6001305, B6001306, B6001307, B6001308, B6001309, B6001310, B6001311, B6001312, B6001313, B6001314, B6001315, B6001316, B6001317, B6001318, B6001319, B6001320, B6001321, B6001322, B6001323, B6001324, B6001325, B6001326, B6001327, B6001328, B6001329, B6001330, B6001331, B6001332, B6001333, B6001336, B6001337, B6001338, B6001339, B6001340, B6001341, B6001342, B6001343, B6001345, B6001346, B6001347, B6001348, B6001349, B6001350, B6001351, B6001353, B6001354, B6001355, B6001356, B6001357, B6001358, B6001359, B6001360, B6001361, B6001362, B6001363, B6001364, B6001365, B6001366, B6001367, B6001368, B6001369, B6001370, B6001371, B6001372, B6001373, B6001374, B6001375, B6001377, B6001378, B6001379, B6001380, B6001381, B6001382, B6001383, B6001384, B6001385, B6001386, B6001387, B6001388, B6001389, B6001390, B6001391, B6001392, B6001393, B6001394, B6001395, B6001396, B6001397, B6001398, B6001399, B6001401, B6001402, B6001403, B6001404, B6001405, B6001406, B6001407, B6001408, B6001409, B6001410, B6001411, B6001413, B6001415, B6001416, B6001418, B6001419, B6001421, B6001422, B6001423, B6001424, B6001425, B6001426, B6001427, B6001432, B6001433, B6001435, B6001436, B6001437, B6001438, B6001439, B6001440, B6001441, B6001442, B6001443, B6001444, B6001445, B6001446, B6001447, B6001448, B6001449, B6001450, B6001451, B6001452, B6001453, B6001454, B6001455, B6001456, B6001457, B6001463, B6001464, B6001465, B6001466, B6001467, B6001468, B6001469, B6001470, B6001471, B6001472, B6001473, B6001474, B6001475, B6001476, B6001477, B6001478, B6001479, B6001481, B6001482, B6001483, B6001485, B6001486, B6001487, B6001488, B6001489, B6001490, B6001491, B6001492, B6001493, B6001495, B6001496, B6001497, B6001498, B6001499, B6001500, B6001501, B6001502, B6001503, B6001505, B6001506, B6001507, B6001508, B6001509, B6001510, B6001511, B6001512, B6001513, B6001514, B6001516, B6001517, B6001518, B6001519, B6001520, B6001522, B6001523, B6001524, B6001525, B6001529, B6001530, B6001532, B6001533, B6001534, B6001539, B6001540, B6001542, B6001545, B6001547, B6001548, and B6001549.

Radiology Devices

2

No

Worldwide Distribution - USA and the countries of Australia, Canada, China, Colombia, European Union, United Kingdom, Saudi Arabia, and Singapore.

BVI 9600 Bladder Volume Instrument, Aorta Scan Mode || The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.