Philips Medical Systems HD11XE Diagnostic Ultrasound System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HD11XE Diagnostic Ultrasound System
Brand
Philips Medical Systems
Lot Codes / Batch Numbers
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.
Products Sold
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.
Philips Medical Systems is recalling HD11XE Diagnostic Ultrasound System due to Potential for erroneous measurements which may lead to incorrect diagnosis based upon the presence of an inaccurate, undetectable error in clinical me. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026