B125P Patient Monitor recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 00840682147224: Model Number 6160000-002-100174, Serial Numbers: SR522350004WA, SR522350001WA, SR522350002WA, SR522350003WA, SR522350005WA, SR522350006WA, SR522350007WA, SR522350008WA, SR522350009WA, SR522350010WA, SR522350011WA, SR522350012WA, SR522350013WA, SR522350014WA, SR522350015WA, SR522350016WA, SR522350017WA, SR522350018WA, SR522350019WA, SR522350020WA, SR522350021WA, SR522350047WA, SR522350048WA, SR522350049WA, SR522350050WA, SR522350088WA, SR522350051WA, SR522350053WA, SR522350054WA, SR522350055WA, SR522350087WA, SR522350089WA, SR522350090WA, SR522350091WA, SR522350092WA, SR522350093WA, SR522350094WA, SR522350095WA, SR522350096WA, SR522350097WA, SR522350098WA, SR522350168WA, SR522350165WA, SR522350166WA, SR522350167WA, SR522350169WA, SR522350170WA, SR522350171WA, SR522350172WA, SR522350173WA, SR522350174WA, SR522350175WA, SR522350176WA, SR522350177WA, SR522350178WA, SR522350179WA, SR522350183WA, SR522350180WA, SR522350181WA, SR522350182WA, SR522350160WA, SR522350161WA, SR522350162WA, SR522350163WA, SR522350164WA, SR522350135WA, SR522350136WA, SR522350137WA, SR522350138WA, SR522350139WA, SR522350140WA, SR522350141WA, SR522350142WA, SR522350143WA, SR522350144WA, SR522350145WA, SR522350146WA, SR522350147WA, SR522350148WA, SR522350149WA, SR522350150WA, SR522350151WA, SR522350152WA, SR522350153WA, SR522350155WA, SR522350156WA, SR522350157WA, SR522350158WA, SR522350159WA, SR522350111WA, SR522350112WA, SR522350116WA, SR522350113WA, SR522350114WA, SR522350115WA, SR522350117WA, SR522350118WA, SR522350119WA, SR522350120WA, SR522350121WA, SR522350122WA, SR522350123WA, SR522350124WA, SR522350125WA, SR522350126WA, SR522350127WA, SR522350128WA, SR522350129WA, SR522350130WA, SR522350131WA, SR522350132WA, SR522350133WA, SR522350134WA, SR522350099WA, SR522350100WA, SR522350101WA, SR522350102WA, SR522350103WA, SR522350104WA, SR522350105WA, SR522350106WA, SR522350107WA, SR522350108WA, SR522350109WA, SR522350110WA, SR522350022WA, SR522350023WA, SR522350024WA, SR522350034WA, SR522350031WA, SR522350032WA, SR522350033WA, SR522350035WA, SR522350036WA, SR522350037WA, SR522350038WA, SR522350039WA, SR522350040WA, SR522350041WA, SR522350042WA, SR522350043WA, SR522350044WA, SR522350045WA, SR522350046WA, SR522350027WA, SR522350028WA, SR522350029WA, SR522350030WA, SR522350026WA, SR522350025WA; Model Number 6160000-002-100767, Serial Numbers: SR522340004WA, SR522340001WA, SR522340002WA, SR522340003WA, SR522340005WA, SR522340006WA, SR522340007WA, SR522340008WA, SR522340009WA, SR522340010WA; Model Number 6160000-002-101962, Serial Numbers: SR522380044WA, SR522380041WA, SR522380042WA, SR522380043WA, SR522380058WA, SR522380055WA, SR522380056WA, SR522380057WA, SR522380059WA, SR522380061WA, SR522380060WA, SR522380062WA, SR522380063WA, SR522380064WA, SR522380065WA, SR522380066WA, SR522380067WA, SR522380068WA, SR522380045WA, SR522380046WA, SR522380047WA, SR522380048WA, SR522380049WA, SR522380050WA, SR522380051WA, SR522380052WA, SR522380053WA, SR522380054WA, SR522380069WA, SR522380070WA, SR522380071WA, SR522380072WA, SR522380073WA, SR522380074WA, SR522380075WA, SR522380076WA, SR522380077WA, SR522380078WA, SR522380079WA, SR522380080WA, SR522380081WA, SR522380082WA, SR522380083WA, SR522380084WA, SR522380085WA, SR522380086WA, SR522380087WA, SR522380088WA, SR522380089WA, SR522380090WA, SR522380092WA, SR522380091WA, SR522380001WA, SR522380027WA, SR522380028WA, SR522380029WA, SR522380030WA, SR522380031WA, SR522380032WA, SR522380034WA, SR522380035WA, SR522380036WA, SR522380037WA, SR522380038WA, SR522380039WA, SR522380040WA, SR522380093WA, SR522380094WA, SR522380095WA, SR522380096WA, SR522380097WA, SR522380098WA, SR522380099WA, SR522380100WA, SR522380101WA, SR522380102WA, SR522380103WA, SR522380104WA, SR522380105WA, SR522380106WA, SR522380107WA, SR522380111WA, SR522380108WA, SR522380109WA, SR522380110WA, SR522380115WA, SR522380112WA, SR522380113WA, SR522380114WA, SR522380116WA; Model Number 6160000-002-753161, Serial Numbers: SR521070001WA, SR521040006WA, SR521040007WA, SR521050002WA, SR521050025WA, SR521050026WA, SR521050027WA, SR521050029WA, SR521050032WA, SR521050033WA, SR521050035WA, SR521050036WA, SR521050038WA, SR521040003WA, SR521050003WA, SR521050004WA, SR521050005WA, SR521050008WA, SR521070006WA, SR521050001WA, SR521050037WA, SR521070003WA, SR521070007WA, SR521040017WA, SR521040022WA, SR521040002WA, SR521040010WA, SR521050034WA, SR521040020WA, SR521050030WA, SR521040009WA, SR521040001WA, SR521040004WA, SR521040008WA, SR521040011WA, SR521040012WA, SR521040014WA, SR521040018WA, SR521070005WA, SR521070004WA, SR521040013WA, SR521040016WA, SR521040019WA, SR521040021WA, SR521040023WA, SR521040015WA, SR521050006WA, SR521050028WA, SR521050031WA, SR521070002WA; Model Number 6160000-002-767129, Serial Numbers: SR521110001WA, SR521110002WA, SR521110003WA, SR521110004WA, SR521110005WA; Model Number 6160000-002-790743, Serial Numbers: SR521230001WA, SR521230002WA, SR521230003WA, SR521230004WA, SR521230005WA, SR521230006WA, SR521300002WA, SR521410008WA, SR521410009WA, SR521410010WA, SR521150001WA, SR521150002WA, SR521150003WA, SR521150004WA, SR522080001WA, SR521260010WA, SR521260011WA, SR521260012WA, SR521260013WA, SR521260014WA, SR521260015WA, SR521220031WA, SR521220028WA, SR521220029WA, SR521220030WA, SR521220032WA, SR521220033WA, SR521220034WA, SR521220035WA, SR521220036WA, SR521220037WA, SR521220038WA, SR521220039WA, SR521450004WA, SR521450003WA, SR521450005WA, SR521460017WA, SR521460014WA, SR521460015WA, SR521460016WA, SR521460018WA, SR521150005WA, SR521300001WA, SR521410004WA, SR521410001WA, SR521410002WA, SR521410003WA, SR521410005WA, SR521410006WA, SR521410007WA, SR521410011WA, SR521450001WA, SR521450002WA, SR521470031WA, SR521470030WA, SR522350066WA, SR522350064WA, SR522350065WA; Model Number 6160000-002-791942, Serial Numbers: SR521150009WA, SR521150006WA, SR521150007WA, SR521150008WA, SR521150010WA, SR521150011WA; Model Number 6160000-002-795077, Serial Numbers: SR521220026WA; Model Number 6160000-002-807391, Serial Numbers: SR521400015WA, SR521400016WA, SR521400017WA, SR521400018WA, SR521400019WA, SR521400020WA, SR521400021WA, SR521400022WA, SR521400007WA, SR521400009WA, SR521400008WA, SR521400010WA, SR521400011WA, SR521200012WA, SR521200009WA, SR521200015WA, SR521200016WA, SR521200017WA, SR521200018WA, SR521200014WA, SR521200019WA, SR521200011WA, SR521200028WA, SR521200020WA, SR521400013WA, SR521200013WA, SR521400014WA, SR521200010WA, SR521400012WA, SR521200021WA, SR521200022WA, SR521200023WA, SR521200027WA, SR521200024WA, SR521200025WA, SR521200026WA, SR521400004WA, SR521400005WA, SR521400006WA; Model Number 6160000-002-811089, Serial Numbers: SR521220005WA, SR521220006WA, SR521220007WA, SR521220008WA, SR521220009WA, SR521220010WA, SR521220011WA; Model Number 6160000-002-813390, Serial Numbers: SR521220012WA, SR521220013WA, SR521220014WA, SR521370012WA; Model Number 6160000-002-815200, Serial Numbers: SR521200040WA, SR521200046WA, SR521200048WA, SR521200049WA, SR521200045WA, SR521200050WA, SR521200051WA, SR521200053WA, SR521210001WA, SR521210003WA, SR521200041WA, SR521200042WA, SR521200043WA, SR521200047WA, SR521200044WA, SR521200039WA, SR521200055WA, SR521200057WA, SR521210002WA, SR521200052WA, SR521200054WA, SR521200056WA; Model Number 6160000-002-816411, Serial Numbers: SR521220015WA, SR521220016WA, SR521220017WA, SR521220018WA; Model Number 6160000-002-818359, Serial Numbers: SR521210011WA, SR521210012WA, SR521210013WA, SR521210014WA; Model Number 6160000-002-832284, Serial Numbers: SR521260001WA, SR521260002WA, SR521260003WA; Model Number 6160000-002-841595, Serial Numbers: SR521270053WA, SR521270051WA, SR521270052WA, SR521270054WA, SR521270055WA, SR521270056WA, SR521270057WA, SR521270058WA, SR521270059WA, SR521270060WA, SR521270038WA, SR521270035WA, SR521270036WA, SR521270037WA, SR521270039WA, SR521270040WA, SR521270041WA, SR521270042WA, SR521270043WA, SR521270044WA, SR521270045WA, SR521270046WA, SR521270047WA, SR521270048WA, SR521270049WA, SR521270019WA, SR521270016WA, SR521270017WA, SR521270018WA, SR521270020WA, SR521270021WA, SR521270022WA, SR521270023WA, SR521270027WA, SR521270029WA, SR521270030WA, SR521270031WA, SR521270032WA, SR521270033WA, SR521270034WA, SR521270050WA, SR521270026WA, SR521270028WA, SR521270024WA, SR521270025WA; Model Number 6160000-002-849738, Serial Numbers: SR521280006WA; Model Number 6160000-002-870236, Serial Numbers: SR521370042WA; Model Number 6160000-002-870818, Serial Numbers: SR521370043WA; Model Number 6160000-002-874089, Serial Numbers: SR521380015WA, SR521380013WA, SR521380014WA; Model Number 6160000-002-874722, Serial Numbers: SR521400003WA; Model Number 6160000-002-905758, Serial Numbers: SR521460049WA, SR521460050WA, SR521460051WA; Model Number 6160000-002-906055, Serial Numbers: SR521470022WA; Model Number 6160000-002-912058, Serial Numbers: SR521470072WA, SR521470073WA, SR521470074WA, SR521470075WA, SR521470076WA, SR521470077WA, SR521470078WA; Model Number 6160000-002-912766, Serial Numbers: SR521460035WA, SR521460036WA, SR521460037WA, SR521460038WA, SR521460039WA, SR521460040WA, SR521460041WA, SR521460042WA, SR521460043WA, SR521460020WA, SR521460026WA, SR521460033WA, SR521460030WA, SR521460021WA, SR521460022WA, SR521460028WA, SR521460032WA, SR521460034WA, SR521460003WA, SR521460004WA, SR521460005WA, SR521460006WA, SR521460007WA, SR521460008WA, SR521460009WA, SR521460010WA, SR521460011WA, SR521460012WA, SR521460024WA, SR521460025WA, SR521460031WA, SR521460027WA, SR521460029WA, SR521460013WA, SR521460023WA; Model Number 6160000-002-914630, Serial Numbers: SR522190006WA, SR522190007WA, SR522190008WA, SR522190009WA, SR522190010WA, SR521470042WA, SR521470043WA; Model Number 6160000-002-935475, Serial Numbers: SR521490001WA; Model Number 6160000-002-943015, Serial Numbers: SR521500004WA, SR521500001WA, SR521500002WA, SR521500003WA, SR521500005WA, SR521500006WA, SR521500007WA, SR521500008WA, SR521500009WA, SR521500010WA, SR521500011WA, SR521500012WA, SR521500013WA, SR521500014WA, SR521500015WA; Model Number 6160000-002-943237, Serial Numbers: SR522350057WA; Model Number 6160000-002-962992, Serial Numbers: SR522110003WA, SR522110002WA, SR522110001WA; Model Number 6160000-002-972536, Serial Numbers: SR522110022WA, SR522110019WA, SR522110020WA, SR522110021WA, SR522110023WA, SR522110024WA, SR522110025WA, SR522110026WA, SR522110027WA, SR522110028WA, SR522110029WA, SR522110030WA, SR522110031WA, SR522110032WA, SR522110033WA, SR522110034WA, SR522110035WA, SR522110036WA, SR522110037WA, SR522110038WA, SR522110039WA, SR522110040WA, SR522110041WA, SR522110042WA, SR522110043WA, SR522110044WA, SR522110045WA, SR522110046WA, SR522110047WA, SR522110048WA, SR522110052WA, SR522110049WA, SR522110050WA, SR522110051WA, SR522110053WA, SR522110091WA, SR522110088WA, SR522110089WA, SR522110090WA, SR522110092WA, SR522110093WA, SR522110094WA, SR522110095WA, SR522110096WA, SR522110097WA, SR522110098WA, SR522110099WA, SR522110100WA, SR522110101WA, SR522110102WA, SR522110103WA, SR522110104WA, SR522110105WA, SR522110106WA, SR522110107WA, SR522110108WA, SR522110109WA, SR522110110WA, SR522110111WA, SR522110112WA, SR522110113WA, SR522110007WA, SR522110004WA, SR522110005WA, SR522110006WA, SR522110008WA, SR522110009WA, SR522110010WA, SR522110011WA, SR522110012WA, SR522110016WA, SR522110013WA, SR522110014WA, SR522110015WA, SR522110017WA, SR522110018WA, SR522110057WA, SR522110054WA, SR522110055WA, SR522110056WA, SR522110058WA, SR522110059WA, SR522110060WA, SR522110061WA, SR522110062WA, SR522110063WA, SR522110064WA, SR522110065WA, SR522110066WA, SR522110067WA, SR522110068WA, SR522110069WA, SR522110070WA, SR522110071WA, SR522110072WA, SR522110073WA, SR522110074WA, SR522110075WA, SR522110076WA, SR522110077WA, SR522110078WA, SR522110079WA, SR522110080WA, SR522110081WA, SR522110082WA, SR522110083WA, SR522110087WA, SR522110084WA, SR522110085WA, SR522110086WA.

Product

B125P Patient Monitor (with E-module slot option), REF 6160000-002

Recalling firm

GE Medical Systems, LLC

Quantity

388 units

Distribution

Worldwide distribution.

Recall date

December 28, 2022

Classification

Class II

Status

Ongoing

Agency

FDA (device)