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U.S. Department of Health and Human Services

Class 2 Device Recall HD11

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 Class 2 Recall
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Date Posted July 03, 2007
Recall Status1 Open
Recall Number Z-0987-2007
Recall Event ID 37888
Premarket Notification
510(K) Number
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product HD11XE Diagnostic Ultrasound System
Code Information DOMESTIC SERIAL NUMBERS: US10670272, US10670282, US10670288, US10670296, US10670304, US10670314, US10670315, US10670316, US10670317, US10670319, US10771576, US10771580, US10771596, US10771610, US10771620, US10771621, US10771622, US10771623, US10771630, US10771631, US10771638, US10771640, US10771641, US10771647, US10771651, US10771658, US10771660, US10771661, US20530061, US20530091, US20670366, US20670392, US20670393, US20771672, US20771674, US20771675, US20771683, US20771685, US20771686, US20771688, US20771689, US20771696, US20771697, US20771718, US20771722, US20771725, US20771726, US20771729, US20771733, US20771734, US20771735, US20771738, US20771739, US20771749, US30670410, US30670411, US30670501, US30670502, US30670509, US30670521, US30771757, US30771757, US30771766, US30771771, US30771772, US30771774, US30771775, US30771782, US30771790, US30771793, US30771809, US30771827, US30771830, US30771831, US30771835, US30771847, US30771848, US30771858, US30771862, US30771865, US40670540, US40670541, US40670573, US40670600, US40670624, US50670631, US50670657, US50670673, US50670707, US50670737, US60530418, US60670757, US60670777, US60670840, US60670841, US60670861, US60670862, US60670872, US60670873, US60670879, US60670880, US70670906, US70670912, US70670913, US70670914, US70670915, US70670947, US70670953, US70670955, US70670975, US80670986, US80670987, US80670990, US80670991, US80670992, US80670997, US80671008, US80671039, US80671040, US80671079, US80671083, US80671084, US90404706, US90531014, US90531073, US90671117, US90671154, US90671161, US90671165, US90671170, US90671178, USD0531367, USD0570096, USD0570114, USD0570161, USD0570195, USD0570200, USD0570207, USD0671475, USD0671490, USD0671493, USD0671497, USD0671498, USD0671503, USD0671504, USD0671505, USD0671510, USD0671511, USD0671527, USD0671531, USD0671532, USD0671533, USD0671542, USD0671546, USD0671547, USD0671548, USD0671550, USD0671553, USD0671554, USD0671555, USD0671556, USD0671567, USD0671572, USN0531226, USN0531237, USN0531243, USN0531256, USN0570005, USN0570014, USN0570031, USN0570036, USN0570044, USN0671319, USN0671320, USN0671321, USN0671322, USN0671323, USN0671325, USN0671326, USN0671341, USN0671351, USN0671352, USN0671353, USN0671360, USN0671362, USN0671367, USN0671370, USN0671378, USN0671406, USN0671407, USN0671408, USN0671410, USN0671413, USN0671414, USN0671418, USN0671422, USN0671423, USO0531081, USO0531087, USO0671212, USO0671214, USO0671254, USO0671260, USO0671263, USO0671271, USO0671285, USO0671286, USO0671287, USO0671288, USO0671289, USO0671290, USO0671291, USO0671293, USO0671294, USO0671304, USO0671311, USO0671315, USO0671316, and USO0671317. INTERNATIONAL SERIAL NUMBERS: US10670302, US10732432, US10771574, US10771578, US10771588, US10771590, US10771591, US10771593, US10771594, US10771595, US10771597, US10771599, US10771601, US10771603, US10771606, US10771607, US10771608, US10771612, US10771617, US10771628, US10771629, US10771632, US10771633, US10771635, US10771636, US10771639, US10771644, US10771646, US10771649, US10771652, US10771654, US10771655, US10771656, US10771657, US10771662, US10771666, US10771667, US10771669, US10771671, US20670326, US20771673, US20771678, US20771680, US20771681, US20771687, US20771691, US20771695, US20771699, US20771701, US20771708, US20771713, US20771714, US20771715, US20771716, US20771727, US20771728, US20771744, US20771747, US30670469, US30670525, US30771756, US30771756, US30771758, US30771759, US30771768, US30771778, US30771780, US30771786, US30771788, US30771792, US30771797, US30771800, US30771802, US30771805, US30771807, US30771810, US30771811, US30771812, US30771815, US30771816, US30771818, US30771819, US30771820, US30771828, US30771832, US30771833, US30771836, US30771837, US30771840, US30771842, US30771843, US30771845, US30771846, US30771849, US30771853, US30771861, US30771861, US40631672, US40670548, US40670551, US40670575, US40670576, US40670577, US50530353, US50670674, US50670745, US60670785, US60670812, US60670813, US60670888, US70670905, US70670911, US70670920, US80530793, US80530809, US80671003, US80671014, US80671074, US80671082, US90671125, US90671175, US90671176, US90671183, US90671192, US90671195, USD0570097, USD0570116, USD0570121, USD0570149, USD0570154, USD0570155, USD0570166, USD0570169, USD0570171, USD0671440, USD0671441, USD0671442, USD0671443, USD0671444, USD0671445, USD0671446, USD0671447, USD0671448, USD0671449, USD0671450, USD0671451, USD0671452, USD0671453, USD0671454, USD0671455, USD0671457, USD0671458, USD0671459, USD0671460, USD0671461, USD0671462, USD0671463, USD0671464, USD0671465, USD0671466, USD0671467, USD0671468, USD0671469, USD0671470, USD0671471, USD0671472, USD0671473, USD0671474, USD0671476, USD0671477, USD0671478, USD0671479, USD0671480, USD0671481, USD0671482, USD0671483, USD0671484, USD0671485, USD0671486, USD0671487, USD0671488, USD0671489, USD0671491, USD0671492, USD0671494, USD0671495, USD0671496, USD0671499, USD0671500, USD0671501, USD0671502, USD0671506, USD0671507, USD0671508, USD0671509, USD0671512, USD0671513, USD0671514, USD0671515, USD0671516, USD0671517, USD0671518, USD0671519, USD0671520, USD0671521, USD0671522, USD0671523, USD0671524, USD0671525, USD0671534, USD0671537, USD0671538, USD0671543, USD0671544, USD0671545, USD0671562, USD0671563, USD0671566, USN0570007, USN0570008, USN0570009, USN0570055, USN0570056, USN0570057, USN0671324, USN0671327, USN0671328, USN0671329, USN0671330, USN0671331, USN0671332, USN0671333, USN0671334, USN0671335, USN0671336, USN0671337, USN0671338, USN0671339, USN0671340, USN0671342, USN0671343, USN0671344, USN0671345, USN0671346, USN0671347, USN0671348, USN0671349, USN0671354, USN0671355, USN0671356, USN0671357, USN0671358, USN0671359, USN0671361, USN0671363, USN0671364, USN0671365, USN0671366, USN0671368, USN0671369, USN0671371, USN0671372, USN0671373, USN0671374, USN0671375, USN0671376, USN0671379, USN0671380, USN0671381, USN0671382, USN0671383, USN0671384, USN0671385, USN0671386, USN0671387, USN0671388, USN0671389, USN0671390, USN0671391, USN0671392, USN0671393, USN0671394, USN0671395, USN0671396, USN0671397, USN0671398, USN0671399, USN0671400, USN0671401, USN0671402, USN0671403, USN0671404, USN0671405, USN0671409, USN0671411, USN0671412, USN0671415, USN0671416, USN0671417, USN0671419, USN0671420, USN0671421, USN0671424, USN0671426, USN0671427, USN0671428, USN0671429, USN0671430, USN0671431, USN0671432, USN0671433, USN0671434, USN0671435, USN0671436, USN0671437, USN0671438, USN0671439, USO0531134, USO0531137, USO0671213, USO0671215, USO0671279, USO0671280, USO0671281, USO0671282, USO0671283, USO0671284, USO0671292, USO0671295, USO0671296, USO0671297, USO0671298, USO0671299, USO0671300, USO0671301, USO0671302, USO0671303, USO0671305, USO0671306, USO0671307, USO0671308, USO0671309, USO0671310, USO0671312, USO0671313, USO0671314, and USO0671318.
Recalling Firm/
Philips Medical Systems
22100 Bothell-Everett Hwy.
P.O. Box 3003
Bothell, Washington 98041-3003
For Additional Information Contact Sarah Baxter
Manufacturer Reason
for Recall
Potential for erroneous measurements which may lead to incorrect diagnosis based upon the presence of an inaccurate, undetectable error in clinical measurement or calculation. If the user exits an imaging mode while Active Annotation is in use, the system can enter an undefined state where the image scale calibration may not match the scale of the on-screen measurements and graphics and possib
FDA Determined
Cause 2
DESIGN: Software Design
Action On 04/25/2007 firm sent letters dated 04/23/2007 to consignees informing them of the issue and that a new software release to correct the issue became available 04/19/2007. The firm's Field Service Representatives will contact consignees to install the new software at no charge to the consignee.
Quantity in Commerce 219 units in US and 347 units distributed internationally
Distribution Worldwide.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = PHILIPS ULTRASOUND, INC.