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B125P Patient Monitor (with E-module slot option), REF… recallZ-0730-2023 · GE Medical Systems, LLC · initiated Nov 16, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Medical Systems, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.

FDA root cause category: Device Design

What the company is doing

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 11/16/2022. The notice explained the problem and safety issue and requested the following: "You can determine whether your monitor is impacted by looking at the side of your monitor where the parameter acquisition connectors are located. B1x5P with E-module slot option and all B1x5M patient monitors are impacted (See Figure 1). B1x5P patient monitors without E-module slot option are not impacted (See Figure 2). You can also determine whether your monitor is impacted following the affected product directions below. You can continue to use the affected monitors by following the safety instructions below. 1. Use CO2 measurement in % unit by following the below steps on the B1x5P / B1x5M monitor. a. From the Main Screen, click the CO2 digit field; b. Select Setup > Unit; c. Select % from the dropdown list. OR If available, you can also insert the GE Healthcare gas E-module for CO2 measurement directly into the E-module slot of the GE Healthcare anesthesia delivery systems (Carestation 600 Series, Carestation 750, Avance CS2, and Aisys CS2) or CARESCAPE R860 ventilator, as the CO2 measurement values displayed on these machines are correct in all "%", mmHg , and kPa units." "If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative." The affected products will be updated.

Recall details

Recall number
Z-0730-2023
Status
Open, Classified
Initiated by the company
Nov 16, 2022
Posted by the FDA
Dec 19, 2022
Recalling firm
GE Medical Systems, LLC
Quantity
388 units
Product code
MHX
FDA submissions
K213490
Distribution
Worldwide distribution.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (12k characters)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

4 devices cleared under K213490 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 91176).

Sources and updates

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