510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-0987-2007

HD11XE Diagnostic Ultrasound System

Philips North America LLC / initiated 2007-04-25 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Philips Medical Systems began a recall of HD11XE Diagnostic Ultrasound System on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0987-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
HD11XE Diagnostic Ultrasound System
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
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
Root cause tag
manufacturing process
FDA root cause
Other
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.
Product codes and lots
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.