Recalling Firm / Manufacturer

Philips Medical Systems

Product

HD11XE Diagnostic Ultrasound System

Code Information

DOMESTIC SERIAL NUMBERS: US20771685, US30771865, US20670392, US20670393, US10771621, US10771622, USD0671510, US40670541, US10771620, USD0671532, USD0570096, US30771809, US50670631, USN0671407, USO0671271, US10670319, US40670573, US10670272, US30670502, US80671079, USN0671418, USD0570114, US60670879, US70670912, US60670757, US60670840, US40670600, US90671178, US20530061, USO0531087, US30771858, US10670304, US30771847, US30771848, US20771674, US90671170, USN0531256, USN0570005, US10771640, US30670501, USD0671542, US20771675, USN0671406, USD0671505, USD0671553, USN0671320, US60670861, US60670862, USO0671263, USN0671423, USD0671548, USO0671289, USO0671290, US50670707, USN0671319, US70670975, US80671083, US10670314, US10670315, US10670316, US10670317, US90531014, US70670906, USN0671323, US80670990, US50670673, US70670947, US80670987, US80670997, US90671154, US70670913, US60670880, USD0671475, US30771766, US20771672, USD0671554, USD0671497, USN0671367, USN0671410, USD0671572, US20771738, US30670521, USN0671326, USO0671285, USO0671286, US70670915, US20771726, USD0671533, USN0671413, USN0671414, US20771689, USD0671556, US70670914, US80671040, US60670777, US80670991, US10771596, US90404706, USO0671311, US60670872, US10771610, US20771683, USN0671360, USO0671288, USN0570031, USO0671260, US30771793, US20771696, US20771697, US20771739, US10771658, USD0671504, USD0531367, US10771647, US80671008, USO0671291, US30670509, USO0671294, US30771790, US10670288, US10670282, USD0671498, USN0671322, USO0671287, US50670737, US90671165, US90671117, USN0671408, USD0671527, US80670992, US30771835, US10670296, USO0671316, USO0671317, USN0531237, US30771831, US30771830, USN0570036, USN0570044, US10771651, US60670841, USN0531226, US10771641, US10771638, USO0671293, US30771782, USO0671304, US10771623, US10771660, US10771661, US30670410, US60670873, US90671161, USD0671567, USN0671370, USD0570200, US30670411, USD0570207, US40670540, US80671084, US70670953, US10771630, US10771631, USO0671254, USD0671550, US50670657, US10771580, US30771827, USD0570161, USD0671490, US30771771, USO0671315, USN0671341, US30771772, US20670366, USO0671214, USD0671531, USN0671362, USN0671321, USN0671422, US30771774, US30771775, USD0671493, USN0671325, USN0671353, US20771729, USN0671378, USO0671212, US20530091, USD0671511, USD0671555, US20771686, USD0570195, US60530418, USN0531243, USD0671546, USD0671547, US70670955, US10771576; INTERNATIONAL SERIAL NUMBERS: US10771662, USD0671448, US20771678, US30771812, USN0671376, USN0671390, USO0671215, USN0671371, USD0671516, USD0671470, USD0671484, US80671082, USN0570009, USN0671354, USN0671355, USO0671307, USO0671308, USO0671309, USO0671310, USN0671387, USN0671388, USN0671428, US10771649, USO0671305, US10771594, USN0671332, USN0671381, USN0671327, US70670905, USD0570169, US40670551, USD0671489, USD0570149, USO0671299, USN0671385, USN0570007, US10670302, USN0671372, USN0671373, US20771708, US10771601, US10771591, USN0570056, USN0570057, USD0570166, USD0570171, US20771695, USD0671467, USN0671438, USD0671483, USD0671463, USD0671494, USD0671495, USN0671430, USN0671386, USD0671451, USN0671429, US60670888, US50670745, US10771654, US70670920, US10771595, USN0671427, USD0671509, USN0570008, US50530353, US30771849, USN0671338, USD0671469, USN0671424, US10771669, US90671183, USO0671284, US90671176, USD0671482, US30670469, US30771842, USD0671538, USD0671462, USN0671395, US20771713, US20771714, US20771715, US20771716, US10732432, USN0671344, USN0671412, US10771588, USN0671357, USN0671343, USD0671512, US90671175, US10771599, US20670326, USD0570121, USN0671335, US60670812, US60670813, USD0671543, USD0671544, USN0671399, US20771701, US40670548, USO0671306, US30771788, USD0570097, US10771646, USO0671314, USD0671515, USN0671334, USO0671292, US90671125, USN0671380, USN0671379, USN0671363, USD0671450, USN0671340, USN0671358, US20771747, USD0570154, US20771727, US30771836, USD0671520, USN0671336, USN0671346, USN0671347, USN0671348, USN0671382, USN0671383, USN0671384, USN0671426, USN0671364, US10771639, USD0671519, US90671192, USD0671481, USD0671480, USN0671415, USD0671566, US20771687, US10771666, USN0671333, USN0671329, USO0671318, US10771574, USD0671461, USD0671466, USD0671474, USN0671339, USN0671421, USD0671521, USD0671522, USN0671439, US10771606, US10771607, US10771608, US10771612, US10771667, US20771681, US20771699, US30771759, US30771780, US30771792, US30771810, US30771833, US30771845, USD0671452, USD0671453, USD0671485, USD0671508, USD0671514, USN0671356, USN0671396, US30771786, US30771807, US30771768, USN0671393, US10771655, USD0671455, USO0671279, US80530793, US80530809, USO0531134, USN0671409, US30771758, USN0671324, US30771797, US30771853, USN0671361, USN0671391, USN0671392, USN0671349, USD0671440, USD0671441, USD0671442, USD0671443, USD0671444, USD0671445, USD0671446, USD0671447, USD0671454, USD0671457, USD0671458, USD0671459, USD0671460, USD0671523, USN0671431, USN0671432, USN0671433, USN0671434, USN0671435, USN0671436, USN0671437, USO0671280, USO0671281, USO0671282, USO0671283, US10771632, US20771691, USD0671471, USD0671517, USD0671524, USN0671359, US30771778, US10771633, US10771635, US10771636, US20771744, USD0671464, USD0671476, USD0671492, USD0671499, USD0671506, USD0671528, USD0671534, USN0671342, USN0671416, USO0671213, USO0531137, US80671074, USN0671394, US10771590, US40631672, US10771656, US10771657, US10771578, USN0671330, USN0671331, USD0671477, US10771671, USD0671478, USD0570116, USD0671473, USD0671472, US10771593, US20771728, US60670785, US30670525, USN0671405, USD0671449, USD0671479, USD0671487, US70670911, USD0671507, USO0671300, US30771800, US30771815, US30771816, US30771818, US30771819, US30771820, US30771832, US30771837, US30771840, US30771846, USD0671562, USD0671563, USN0671397, USN0671398, USD0671500, US20771680, US10771644, US30771843, USO0671297, USD0671468, USD0671465, US10771597, US30771828, US10771629, US10771603, US10771617, USD0671501, USD0671502, USN0671365, US30771802, USO0671295, USO0671296, US20771673, US10771652, US30771805, USN0671328, USN0671366, USN0671374, USN0671375, USN0671389, US40670576, US40670575, US40670577, USD0671518, USN0671345, USD0570155, USN0671417, US50670674, USD0671545, USN0671337, USN0671401, USN0671402, USN0671403, USN0671404, USN0671411, USO0671301, USO0671302, USO0671303, USO0671313, US80671003, USN0570055, USD0671491, USD0671496, USD0671513, USN0671368, USN0671369, US30771811, USN0671420, US80671014, USD0671486, USD0671488, USD0671537, USO0671298, USN0671400, USO0671312, US90671195, USN0671419, US10771628.

Reason of 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

Date Recall Initiated

April 25, 2007

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. Firm Initiated recall is ongoing.

Contact

Al-Faisaliah Medical Systems
01 / 4656551

Source of Information

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.