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U.S. Department of Health and Human Services

Class 2 Device Recall MRI Patient Monitoring System

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 Class 2 Recall
MRI Patient Monitoring System
see related information
Date Posted October 25, 2011
Recall Status1 Terminated on November 15, 2012
Recall Number Z-0106-2012
Recall Event ID 58984
Premarket Notification
510(K) Number
K090785 
Product Classification Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) - Product Code MWI
Product "***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI Patient Monitoring System Model 865214***Use only with Model 989803169201 Power Adapter***REF 453564155341***SN US11401652***". Note: REF 453564155341, REF 453564181201, and 453564180091 are subject to recall. REF is the firms Service Number which identifies the device. Product Usage 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 of the MR scanner.
Code Information Serial Numbers: US00200747 US00200119 US00200132 US00200133 US00200134 US00200135 US00200136 US00200139 US00200140 US00200141 US00200142 US00200143 US00200144 US00200162 US00200163 US00200164 US00200165 US00200166 US00200167 US00200168 US00200169 US00200170 US00200171 US00200172 US00200173 US00200192 US00200193 US00200194 US00200195 US00200196 US00200197 US00200219 US00200220 US00200221 US00200222 US00200223 US00200224 US00200238 US00200239 US00200240 US00200241 US00200242 US00200243 US00200258 US00200259 US00200260 US00200261 US00200262 US00200263 US00200283 US00200284 US00200285 US00200286 US00200292 US00200293 US00200294 US00200295 US00200296 US00200299 US00200300 US00200301 US00200302 US00200343 US00200344 US00200345 US00200352 US00200354 US00200361 US00200362 US00200371 US00200372 US00200381 US00200382 US00200383 US00200393 US00200394 US00200395 US00200396 US00200399 US00200434 US00200435 US00200436 US00200454 US00200455 US00200456 US00200457 US00200458 US00200459 US00200528 US00200529 US00200530 US00200531 US00200532 US00200557 US00200558 US00200560 US00200561 US00200562 US00200563 US00200564 US00200565 US00200566 US00200567 US00200568 US00200569 US00200600 US00200601 US00200602 US00200603 US00200619 US00200621 US00200636 US00200667 US00200668 US00200669 US00200670 US00200671 US00200672 US00200673 US00200674 US00200687 US00200688 US00200689 US00200690 US00200709 US00200726 US00200727 US00200729 US00200736 US00200737 US00200742 US00200743 US00200744 US00200745 US00200746 US00200749 US00200750 US00200770 US00200780 US00200784 US00200785 US00200812 US00200823 US00200824 US00200827 US00200828 US00200829 US00200830 US00200831 US00200851 US00200865 US00200866 US00200872 US00200873 US00200888 US00200889 US00200890 US00200891 US00200892 US00200893 US00200907 US00200908 US00200909 US00200915 US00200916 US00200917 US00200918 US00200919 US00200920 US00200921 US00200922 US00200923 US00200932 US00200933 US00200958 US00200959 US00200960 US00200961 US00200966 US00200967 US00200968 US00200975 US00200977 US00200978 US00200984 US00200990 US00201002 US00201003 US00201022 US00201023 US00201024 US00201025 US00201053 US00201054 US00201055 US00201056 US00201057 US00201058 US00201065 US00201066 US00201067 US00201068 US00201112 US00201113 US00201114 US00201115 US00201116 US00201117 US00201118 US00201131 US00201132 US00201133 US00201135 US00201137 US00201146 US00201147 US00201148 US00201149 US00201150 US00201151 US00201152 US00201162 US00201210 US00201213 US00201214 US00201215 US00201216 US00201217 US00201219 US00201221 US00201222 US00201223 US00201224 US00201225 US00201226 US00201227 US00201229 US00201230 US00201251 US00201252 US00201253 US00201254 US00201255 US00201256 US00201257 US00201258 US00201259 US00201260 US00201261 US00201262 US00201297 US00201298 US00201299 US00201300 US00201301 US00201302 US00201303 US00201304 US00201305 US00201306 US00201364 US00201365 US00201368 US00201381 US00201382 US00201383 US00201384 US00201385 US00201386 US00201388 US00201389 US00201408 US00201409 US00201417 US00201451 US00201452 US00201453 US93600111 US93600112 US93600113 US93600114 US93600142 US93600144 US93600167 US93600170
Recalling Firm/
Manufacturer
Invivo Corporation
12151 Research Pkwy
Suite 200
Orlando, Florida 32826-3222
For Additional Information Contact Lee Ann Rogus
407-275-3220 Ext. 171
Manufacturer Reason
for Recall
Philips Invivo Corporation of Orlando, FL is recalling their Expression MRI Patient Monitoring System. During transport of the system's cart with a docked Display Controller Unit (DCU), a front caster (wheel) may become loose and fall off causing the cart to become unbalanced and fall.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Philips Invivo Corporation issued a Field Safety Notice "URGENT - MEDICAL DEVICE RECALL" letter to all affected customers notifying them that the Expression MRI Patient Monitoring System could pose a risk for patients and users. The notice identifies the following: what the problem is and under what circumstances it can occur; the actions that should be taken by the user in order to prevent risks for patients or users and the actions planned by Philips Invivo to correct the problem. This notice contains important information for the continued safe and proper use of the equipment and customers were advised to retain a copy with the equipment Instruction for Use. Customers were instructed to contact Philips Invivo Customer Support at (877) 468-4861 (option 1, then option 3) for questions or support concerning this issue.
Quantity in Commerce 285 units
Distribution Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI., SC, SD, TN, TX, VA, WA, and WI and the countries of: Australia, Austria, Canada, Denmark, Germany, Israel, Malaysia, Netherlands, Norway, Singapore, Spain, Switzerland and, United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MWI and Original Applicant = INVIVO CORP.
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