Recalls / —

—#52082

Product

HD11XE Diagnostic Ultrasound System

FDA product code

IYN — System, Imaging, Pulsed Doppler, Ultrasonic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K043535

Affected lot / code info

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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, 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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.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Philips Medical Systems

Address

22100 Bothell-Everett Hwy. P.O. Box 3003, Bothell, Washington 98041-3003

Distribution

Distribution pattern

Worldwide.

Timeline

Recall initiated

2007-04-25

Posted by FDA

2007-07-03

Terminated

2011-01-24

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #52082. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.