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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63643

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 15, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Invivo Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0468-2013
Recall number
Z-0468-2013
Initiated
October 15, 2012
Classification
Class II
Status
Terminated
Recalling firm
Invivo Corporation
Quantity
543 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

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.