Events

Recall of Invivo Corporation Expression MRI Patient Monitoring System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invivo Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63643
  • Event Risk Class
    Class 2
  • Event Number
    Z-0468-2013
  • Event Initiated Date
    2012-10-15
  • Event Date Posted
    2012-12-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114405
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
  • Reason
    Invivo corporation located at 12151 research parkway, orlando, fl 32826 is recalling the expression mri patient monitoring system because during transport of the systems cart with a docked display controller unit (dcu), a caster (wheel) may become detached. if this occurs, the cart can become unbalanced and may fall.
  • Action
    Philips Healthcare sent an "URGENT-MEDICAL DEVICE RECALL" letter dated October 15, 2012 to all affected customers. The letter identified the product, problem, and actons to be taken by the customers. Customers were instructed to inspect all casters of the unit to ensure that they are all secured. If a caster is loose, customers were told to lock the caster in place, limit movement of the cart and contact their local Phillips Invivo Representative. Nevertheless, a Philips Invivo representative will contact the customer regarding their affected device. All affected devices will have new casters installed in order to correct the problem. Contact your local Philips Invivo Representative at 1-800-722-9377 for further information and support.

Device

Invivo Corporation Expression MRI Patient Monitoring System
  • Model / Serial
    Model number 865214: (Service Numbers 453564180091, 453564181201). Lot numbers: US00201487, US00201488, US00201489, US00201490, US00201493, US11401510, US11401511, US11401513, US11401514, US11401515, US11401516, US11401531, US11401532, US11401533, US11401546, US11401562, US11401563, US11401564, US11401565, US11401566, US11401567, US11401568, US11401569, US11401570, US11401571, US11401572, US11401573, US11401574, US11401575, US11401576, US11401577, US11401578, US11401579, US11401611, US11401617, US11401618, US11401631, US11401633, US11401634, US11401645, US11401646, US11401647, US11401648, US11401649, US11401651, US11401652, US11401672, US11401673, US11401674, US11401675, US11401712, US11401713, US11401714, US11401715, US11401716, US11401717, US11401718, US11401719, US11401720, US11401721, US11401722, US11401723, US11401724, US11401737, US11401738, US11401739, US11401740, US11401741, US11401742, US11401743, US11401744, US11401745, US11401746, US11401747, US11401775, US11401776, US11401777, US11401778, US11401779, US11401780, US11401781, US11401782, US11401783, US11401784, US11401785, US11401786, US11401799, US11401843, US11401844, US11401845, US11401846, US11401851, US11401871, US11401872, US11401882, US11401883, US11401884, US11401885, US11401886, US11401892, US11401893, US11401903, US11401904, US11401905, US11401916, US11401917, US11401918, US11401969, US11401970, US11401971, US11401972, US11401973, US11401974, US11401975, US13301988, US13301989, US13301990, US13301991, US13301992, US13301993, US13301994, US13301995, US13301996, US13301997, US13301998, US13302000, US13302001, US13302034, US13302035, US13302036, US13302037, US13302039, US13302040, US13302041, US13302042, US13302043, US13302044, US13302050, US13302051, US13302052, US13302054, US13302055, US13302094, US13302095, US13302096, US13302097, US13302098, US13302099, US13302107, US13302108, US13302109, US13302111, US13302112, US13302113, US13302114, US13302115, US13302117, US13302118, US13302119, US13302141, US13302148, US13302175, US13302176, US13302177, US13302178, US13302179, US13302180, US13302182, US13302192, US13302193, US13302194, US13302195, US13302196, US13302197, US13302198, US13302209, US13302210, US13302211, US13302212, US13302247, US13302248, US13302249, US13302250, US13302251, US13302252, US13302254, US13302265, US13302266, US13302267, US13302291, US13302292, US13302293, US13302294, US13302295, US13302296, US13302297, US13302298, US13302300, US13302302, US13302304, US13302346, US13302347, US13302348, US13302349, US13302350, US13302362, US13302363, US13302364, US13302365, US13302366, US13302367, US13302373, US13302378, US13302421, US13302422, US13302423, US13302424, US13302425, US13302427, US13302430, US13302431, US13302432, US13302434, US13302437, US13302438, US13302439, US13302441, US13302445, US13302446, US13302447, US13302449, US13302450, US13302478, US13302485, US13302488, US13302498, US13302501, US13302503, US13302504, US13302505, US13302507, US13302508, US13302509, US13302510, US13302511, US13302512, US13302513, US13302514, US13302515, US13302516, US13302517, US13302519, US13302520, US13302521, US13302522, US13302523, US13302524, US13302525, US13302526, US13302527, US13302528, US13302529, US13302609, US13302610, US13302612, US13302613, US13302614, US13302617, US13302618, US13302619, US13302620, US13302621, US13302622, US13302623, US13302624, US13302625, US13302631, US13302641, US13302642, US13302644, US13302645, US13302646, US13302647, US13302648, US13302649, US13302650, US13302651, US13302652, US13302653, US13302654, US13302656, US13302657, US13302658, US13302701, US13302702, US13302703, US13302704, US13302705, US13302706, US13302708, US13302709, US13302710, US13302713, US13302714, US13302715, US13302716, US13302717, US13302782, US13302783, US13302784, US13302785, US13302786, US13302787, US13302788, US13302789, US13302790, US13302804, US13302805, US13302806, US13302807, US13302808, US13302809, US13302810, US13302811, US13302812, US13302837, US13302852, US13302853, US13302854, US13302855, US13302856, US13302864, US13302865, US13302866, US13302871, US13302872, US13302873, US13302874, US13302875, US13302878, US13302879, US13302880, US13302881, US13302882, US13302883, US13302887, US13302888, US13302914, US13302915, US13302937, US13302938, US13302939, US13302940, US13302941, US13302942, US13302943, US13302944, US13302954, US13302955, US13302956, US13302957, US13302958, US13302959, US13302960, US13302982, US13302983, US13302985, US13302986, US13302987, US13302988, US13302989, US13302990, US13302991, US13302992, US13302993, US13302998, US13302999, US13303000, US13303001, US13303002, US13303048, US13303049, US13303050, US13303051, US13303052, US13303053, US13303054, US13303055, US13303056, US13303057, US13303080, US13303084, US13303085, US13303086, US13303126, US13303127, US13303128, US13303129, US13303130, US13303158, US13303159, US13303160, US13303161, US13303162, US13303163, US13303178, US13303179, US13303180, US13303187, US13303188, US13303203, US13303214, US13303216, US13303217, US13303219, US13303221, US13303222, US13303223, US13303224, US13303238, US13303239, US13303240, US13303241, US13303243, US13303244, US13303245, US13303270, US13303271, US13303272, US13303273, US13303288, US13303298, US13303306, US13303325, US13303326, US13303327, US13303328, US13303329, US13303330, US13303331, US13303332, US13303333, US13303334, US13303347, US13303348, US13303349, US13303350, US13303351, US13303352, US13303380, US13303381, US13303382, US13303383, US13303384, US13303387, US13303388, US13303409, US13303413, US13303414, US13303416, US13303417, US13303418, US13303419, US13303420, US13303421, US13303422, US13303436, US13303462, US13303463, US13303464, US13303465, US13303466, US13303467, US13303468, US13303482, US13303488, US13303489, US13303490, US13303499, US13303500, US13303501, US13303502, US13303503, US13303504, US13303505, US13303506, US13303507, US13303508, US13303509, US13303510, US13303511, US13303512, US13303543, US13303544, US13303573, US13303574, US13303575, US13303576, US13303577, US13303578, US13303579, US13303580, US13303584, US13303585, US13303586, US13303587, US13303588, US13303589, US13303590, US13303591, US13303597, US13303598, US13303601, US13303625, US13303626, US13303627, US13303628, US13303630, US13303631, US13303662, US13303665, US13303666, US13303667, US13303668, US13303671, US13303672, US13303721, US13303722, US13303723, US13303724, US13303725, US13303726, US13303727, US13303733, US13303734, US13303735, US13303738, US13303739, US13303748, US13303749, US13303750, US13303780, US13303781
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of MO; MS; MA; IL; OH; NY; KS; PA; WI; VA; SD; AZ; FL; OR; TX; MA; MO; FL; MA; MI; CT; CA; NJ; NC; ME; IL; MA; MA; WV; MA; MN; CA; AL; AL; WI; DC; OH; WV; CA; NC; NY; MT; NJ; CA; WA; IN; MI; PA; TX; NC; TN; TX; ID; NM; IL; PA; IN; IL; WA; CO; MN; CA; IN; MD; MI; DC; GA; DE; CO; CT; WA; NJ; MD; TX; TN; MN; WA; CA; FL; OH; PA; NY; IN; OK; ID; IA; NY; WI; VA; CA; HI; MS; TX; HI; CT; TN; OR; WA; PA; NH; CA; MA; LA; IN; PA; AZ; GA; UT; ND; GA; TX; TX; IN; CA; MI; CT; CA; NC; MS; VA; IN; MI; NE; NV; MI; WA; IL; KY; LA; OR; OK; LA; TN; KY; TX; CA; PA; NM; NC; CO; DC; AL; MI; TX; SD; PA; OR; ID; NM; SD; CO; MN; NJ; MI; ND; MN; MT; LA; CT; WA; TX; IA; NJ; WI; SD; and UT, and the countries of Canada, Italy, Thailand, Russian Federation, Saudi Arabia, Slovenia, Singapore, Republic of Korea, Uzbekistan, Iceland, Israel, Austria, United Kingdom, Afganhistan, Japan, South Africa, Germany, Qatar, Netherlands, Switzerland, Denmark, and Sweden.
  • Product Description
    Invivo Corporation Expression MRI Patient Monitoring System. || The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.
  • Manufacturer
    Invivo Corporation

Manufacturer

Invivo Corporation
  • Manufacturer Address
    Invivo Corporation, 12151 Research Pkwy, Suite 200, Orlando FL 32826-3222
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA