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U.S. Department of Health and Human Services

Class 2 Device Recall Precess MRI Patient Monitoring System

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 Class 2 Recall
Precess MRI Patient Monitoring System
see related information
Date Posted October 27, 2011
Recall Status1 Terminated on August 07, 2013
Recall Number Z-0113-2012
Recall Event ID 60025
Premarket Notification
510(K) Number
K053462 
Product Classification Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) - Product Code MWI
Product Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and HE97B, 94044, 94045 (radio and radio kits). Label located on the back of the WPU. Product is labeled in part: "***Invivo Corporation 12601 Research Parkway, Orlando, FL 32826***Made in U.S.A.***REF 3160***SN***CAUTION: Law in U.S.A. Canada and EU restricts this device to sale by or on the order of of a licensed medical practitioner only.***" Label located on the bottom of the DCU. Product is labeled in part: ***Invivo Corporation 12601 Research Parkway Orlando, FL 32826 Made in U.S.A.***REF 3160DCU***SN***CAUTION: Law in U.S.A. Canada and EU restricts this device to sale by or on the order of of a licensed medical practitioner only.***" Display Controller Unit (DCU) is labeled in part: "***Invivo***PRECESS***". Wireless Processing Unit (WPU) is labeled in part: "***Invivo***". NOTE: WPU AND DCU MAY HAVE THE SAME OR DIFFERENT SERIAL NUMBERS. The radio is responsible for wireless communication between the Wireless Processing Unit and the Display Controller Unit. Precess is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures.
Code Information WPU Serial Numbers 00101 00120 00123 00125 00129 00130 00131 00132 00133 00134 00135 00137 00140 00141 00142 00143 00145 00152 00158 00159 00161 00165 00166 00168 00176 00181 00187 00188 00192 00196 00199 00207 00216 00217 00218 00220 00230 00244 00245 00249 00250 00267 00269 00270 00273 00274 00289 00292 00293 00294 00298 00310 00312 00319 00321 00322 00330 00332 00341 00346 00348 00350 00356 00363 00365 00367 00375 00389 00390 00392 00455 00456 00457 00467 00474 00479 00484 00486 00491 00492 00528 00537 00540 00554 20261 0000A30136 0000A30170 0000A30174 0000A30175 0000A30177 0000A30198 0000A30208 0000A30213 0000A30264 0000A30278 0000A30288 0000A30295 0000A30307 0000A30352 0000A30365 0000A30371 0000A30402 0000A30420 0000A30420 0000A30432 0000A30440 0000A30449 0000A30466 0000A30468 0000A30469 0000A30471 0000A30472 0000A30473 0000A30478 0000A30500 0000A30512 0000A30514 0000A30518 0000A30525 0000A30526 0000A30538 0000A30539 0000A30540 0000A30541 0000A30542 0000A30543 0000A30544 0000A30545 0000A30546 0000A30548 0000A30549 0000A30550 0000A30553 0000A30556 0000A30557 0000A30558 0000A30559 0000A30560 0000A30561 0000A30562 0000A30564 0000A30565 0000A30566 0000A30569 0000A30570 0000A30573 0000A30575 0000A30576 0000A30578 0000A30580 0000A30581 0000A30587 0000A30589 0000A30593 0000A30595 0000A30598 0000A30599 0000A30600 0000A30601 0000A30602 0000A30603 0000A30607 0000A30609 0000A30613 0000A30614 0000A30616 0000A30622 0000A30624 0000A30629 0000A30631 0000A30632 0000A30633 0000A30634 0000A30635 0000A30638 0000A30639 0000A30644 0000A30645 0000A30647 0000A30648 0000A30649 0000A30652 0000A30653 0000A30656 0000A30657 0000A30661 0000A30662 0000A30670 0000A30671 0000A30673 0000A30674 0000A30677 0000A30678 0000A30680 0000A30681 0000A30682 0000A30685 0000A30687 0000A30688 0000A30689 0000A30690 0000A30692 0000A30693 0000A30694 0000A30695 0000A30696 0000A30697 0000A30698 0000A30699 0000A30700 0000A30701 0000A30702 0000A30703 0000A30705 0000A30706 0000A30707 0000A30714 0000A30716 0000A30725 0000A30731 0000A30732 0000A30734 0000A30735 0000A30737 0000A30738 0000A30740 0000A30742 0000A30743 0000A30745 0000A30747 0000A30748 0000A30749 0000A30750 0000A30751 0000A30753 0000A30754 0000A30755 0000A30756 0000A30757 0000A30758 0000A30759 0000A30761 0000A30762 0000A30763 0000A30764 0000A30765 0000A30766 0000A30767 0000A30768 0000A30772 0000A30774 0000A30782 0000A30783 0000A30784 0000A30785 0000A30786 0000A30787 0000A30788 0000A30789 0000A30790 0000A30791 0000A30792 0000A30793 0000A30794 0000A30795 0000A30796 0000A30800 0000A30806 0000A30807 0000A30811 0000A30831 0000A30835 0000A30836 0000A30838 0000A30839 0000A30840 0000A30841 0000A30844 0000A30845 0000A30846 0000A30847 0000A30848 0000A30849 0000A30850 0000A30851 0000A30852 0000A30855 0000A30857 0000A30858 0000A30859 0000A30860 0000A30864 0000A30868 0000A30869 0000A30870 0000A30871 0000A30872 0000A30873 0000A30877 0000A30878 0000A30879 0000A30881 0000A30882 0000A30884. DCU Serial Numbers 00100 00101 00120 00123 00125 00129 00131 00132 00133 00134 00135 00137 00140 00141 00142 00143 00145 00147 00148 00152 00153 00155 00157 00160 00161 00166 00168 00176 00178 00179 00180 00185 00191 00196 00197 00198 00199 00204 00207 00209 00215 00216 00217 00220 00224 00226 00230 00242 00244 00245 00259 00267 00269 00270 00273 00274 00289 00292 00293 00294 00298 00300 00317 00320 00321 00330 00332 00340 00341 00344 00346 00368 00370 00375 00376 00389 00390 00392 00396 00406 00409 00410 00413 00414 00422 00432 00436 00455 00455 00456 00457 00467 00474 00475 00478 00479 00483 00484 00491 00492 00502 00503 00504 00513 00524 00537 00540 00554 20128 20129 20130 20134 20135 20146 20151 20152 20155 20162 20171 20180 20181 20185 20192 20199 20200 20201 20206 20207 20214 20218 20220 20225 20226 20227 20231 20234 20240 20248 20254 20261 20263 20268 20271 20272 20284 20298 20299 20300 20301 20304 20307 20309 20312 20318 20319 20328 20330 20331 20334 20352 20362 0000A30136 0000A30174 0000A30175 0000A30177 0000A30182 0000A30183 0000A30189 0000A30191 0000A30198 0000A30207 0000A30208 0000A30212 0000A30213 0000A30229 0000A30243 0000A30264 0000A30278 0000A30283 0000A30288 0000A30295 0000A30301 0000A30307 0000A30313 0000A30314 0000A30319 0000A30335 0000A30352 0000A30359 0000A30365 0000A30375 0000A30376 0000A30387 0000A30396 0000A30402 0000A30404 0000A30405 0000A30410 0000A30420 0000A30420 0000A30432 0000A30434 0000A30439 0000A30440 0000A30449 0000A30450 0000A30453 0000A30457 0000A30458 0000A30463 0000A30465 0000A30466 0000A30468 0000A30469 0000A30471 0000A30472 0000A30473 0000A30474 0000A30483 0000A30484 0000A30488 0000A30500 0000A30501 0000A30506 0000A30509 0000A30512 0000A30513 0000A30514 0000A30518 0000A30519 0000A30520 0000A30525 0000A30526 0000A30527 0000A30529 0000A30538 0000A30539 0000A30540 0000A30541 0000A30542 0000A30543 0000A30544 0000A30545 0000A30545 0000A30546 0000A30547 0000A30548 0000A30549 0000A30550 0000A30551 0000A30552 0000A30553 0000A30554 0000A30555 0000A30556 0000A30557 0000A30558 0000A30559 0000A30560 0000A30561 0000A30562 0000A30563 0000A30564 0000A30565 0000A30566 0000A30567 0000A30568 0000A30569 0000A30570 0000A30571 0000A30572 0000A30573 0000A30574 0000A30575 0000A30576 0000A30577 0000A30578 0000A30579 0000A30580 0000A30581 0000A30582 0000A30583 0000A30584 0000A30585 0000A30586 0000A30587 0000A30588 0000A30589 0000A30593 0000A30594 0000A30595 0000A30596 0000A30597 0000A30598 0000A30599 0000A30600 0000A30601 0000A30602 0000A30603 0000A30607 0000A30608 0000A30609 0000A30610 0000A30611 0000A30613 0000A30614 0000A30616 0000A30617 0000A30618 0000A30619 0000A30620 0000A30621 0000A30622 0000A30623 0000A30624 0000A30626 0000A30627 0000A30628 0000A30629 0000A30630 0000A30631 0000A30632 0000A30633 0000A30634 0000A30635 0000A30636 0000A30637 0000A30638 0000A30639 0000A30640 0000A30641 0000A30642 0000A30643 0000A30644 0000A30645 0000A30646 0000A30647 0000A30648 0000A30649 0000A30650 0000A30652 0000A30653 0000A30654 0000A30655 0000A30656 0000A30657 0000A30658 0000A30659 0000A30660 0000A30661 0000A30662 0000A30663 0000A30663 0000A30664 0000A30665 0000A30666 0000A30667 0000A30668 0000A30669 0000A30670 0000A30671 0000A30672 0000A30673 0000A30674 0000A30675 0000A30676 0000A30677 0000A30678 0000A30679 0000A30680 0000A30681 0000A30682 0000A30683 0000A30684 0000A30685 0000A30686 0000A30687 0000A30688 0000A30689 0000A30690 0000A30692 0000A30693 0000A30694 0000A30695 0000A30696 0000A30697 0000A30698 0000A30699 0000A30700 0000A30701 0000A30702 0000A30703 0000A30704 0000A30705 0000A30706 0000A30707 0000A30709 0000A30710 0000A30711 0000A30712 0000A30713 0000A30714 0000A30716 0000A30718 0000A30719 0000A30721 0000A30722 0000A30723 0000A30725 0000A30731 0000A30732 0000A30734 0000A30735 0000A30737 0000A30738 0000A30739 0000A30740 0000A30741 0000A30742 0000A30743 0000A30744 0000A30745 0000A30746 0000A30747 0000A30748 0000A30749 0000A30750 0000A30751 0000A30752 0000A30753 0000A30754 0000A30755 0000A30756 0000A30757 0000A30758 0000A30759 0000A30760 0000A30761 0000A30762 0000A30763 0000A30764 0000A30765 0000A30766 0000A30767 0000A30768 0000A30769 0000A30770 0000A30771 0000A30772 0000A30773 0000A30774 0000A30775 0000A30776 0000A30777 0000A30778 0000A30779 0000A30780 0000A30781 0000A30782 0000A30783 0000A30784 0000A30785 0000A30786 0000A30787 0000A30788 0000A30789 0000A30790 0000A30791 0000A30792 0000A30793 0000A30794 0000A30795 0000A30796 0000A30797 0000A30799 0000A30800 0000A30802 0000A30803 0000A30804 0000A30805 0000A30806 0000A30807 0000A30808 0000A30811 0000A30831 0000A30832 0000A30833 0000A30834 0000A30835 0000A30836 0000A30837 0000A30838 0000A30839 0000A30840 0000A30841 0000A30842 0000A30843 0000A30844 0000A30845 0000A30846 0000A30847 0000A30848 0000A30849 0000A30850 0000A30851 0000A30852 0000A30853 0000A30854 0000A30855 0000A30856 0000A30857 0000A30858 0000A30859 0000A30860 0000A30861 0000A30862 0000A30863 0000A30864 0000A30865 0000A30866 0000A30868 0000A30869 0000A30870 0000A30871 0000A30872 0000A30873 0000A30874 0000A30875 0000A30876 0000A30877 0000A30878 0000A30879 0000A30880 0000A30881 0000A30882 0000A30883 0000A30884
Recalling Firm/
Manufacturer
Invivo Corporation
12151 Research Pkwy
Suite 200
Orlando, Florida 32826-3222
Manufacturer Reason
for Recall
Philips Invivo has determined that it is possible for the system's alarm limits and other device settings to spontaneously change without user intervention. This problem is associated with intermittent and frequent loss of communication between the wireless Processing Unit and the Display Controller Unit.
FDA Determined
Cause 2
DESIGN: Device Design
Action A Field Safety Notice entitled Urgent - Medical Device Correction letter, dated September 2011, with attached Field Safety Notice for customers were sent to distributors. The letter described the reason for the recall and the intention of the Field Safety Notice. Also, the hazards involved and instructions on how to identify units that are affected by the recall were provided . The actions to be taken by the user and the actions planned by the Philips Invivo were explained. Users were to follow the instructions provided on how to safely use the device until the unit can be serviced by Philips Invivo. For further information or support concerning this issue, customers are to contact Philips Invivo Customer Support at (877)-468-4861 or their local Philips Invivo representative.
Quantity in Commerce 875
Distribution Worldwide Distribution -- Australia, Austria, Brazil, Canada, China, France, Germany, Malaysia, Norway, Portugal, Spain, Sweden, The Netherlands, United Arab Emirates, United Kingdom, and US.
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 CORPORATION
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