Class 2 Device Recall GE

• Date Initiated by Firm: November 16, 2022
• Date Posted: December 19, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0729-2023
• Recall Event ID: 91176
• 510(K)Number: K213490
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
• Code Information: UDI/DI 00840682147217: Model Number 6160000-001-100174, Serial Numbers: SR422332028WA, SR422332025WA, SR422332026WA, SR422332027WA, SR422332029WA, SR422332030WA, SR422332031WA, SR422332032WA, SR422332049WA, SR422332050WA, SR422332051WA, SR422332052WA, SR422332053WA, SR422332054WA, SR422332055WA, SR422332056WA, SR422332057WA, SR422332061WA, SR422332058WA, SR422332059WA, SR422332060WA, SR422332062WA, SR422332063WA, SR422332064WA, SR422332047WA, SR422332044WA, SR422332045WA, SR422332046WA, SR422332048WA, SR422332033WA, SR422332034WA, SR422332035WA, SR422332036WA, SR422332037WA, SR422332038WA, SR422332039WA, SR422332040WA, SR422332041WA, SR422332042WA, SR422332043WA, SR422332017WA, SR422332018WA, SR422332019WA, SR422332020WA, SR422332021WA, SR422332022WA, SR422332023WA, SR422332024WA, SR422332065WA, SR422332066WA, SR422332067WA, SR422332068WA, SR422332069WA, SR422332070WA, SR422332071WA, SR422332072WA, SR422332081WA, SR422332082WA, SR422332083WA, SR422332084WA, SR422332085WA, SR422332086WA, SR422332087WA, SR422332088WA, SR422332089WA, SR422332090WA, SR422332094WA, SR422332091WA, SR422332092WA, SR422332093WA, SR422332096WA, SR422332095WA, SR422332113WA, SR422332114WA, SR422332115WA, SR422332116WA, SR422332117WA, SR422332118WA, SR422332119WA, SR422332120WA, SR422332121WA, SR422332122WA, SR422332123WA, SR422332127WA, SR422332129WA, SR422332135WA, SR422332136WA, SR422332137WA, SR422332001WA, SR422332002WA, SR422332003WA, SR422332004WA, SR422332005WA, SR422332006WA, SR422332007WA, SR422332008WA, SR422332009WA, SR422332010WA, SR422332011WA, SR422332015WA, SR422332012WA, SR422332013WA, SR422332014WA, SR422332016WA, SR422332073WA, SR422332077WA, SR422332074WA, SR422332075WA, SR422332076WA, SR422332078WA, SR422332079WA, SR422332080WA, SR422332097WA, SR422332098WA, SR422332099WA, SR422332100WA, SR422332101WA, SR422332102WA, SR422332103WA, SR422332104WA, SR422332105WA, SR422332106WA, SR422332107WA, SR422332108WA, SR422332109WA, SR422332110WA, SR422332111WA, SR422332112WA, SR422332177WA, SR422332174WA, SR422332175WA, SR422332176WA, SR422332178WA, SR422332179WA, SR422332180WA, SR422332181WA, SR422332182WA, SR422332183WA, SR422332184WA, SR422332185WA, SR422332186WA, SR422332187WA, SR422332188WA, SR422332192WA, SR422332189WA, SR422332190WA, SR422332191WA, SR422332193WA, SR422332194WA, SR422332195WA, SR422332196WA, SR422332197WA, SR422332198WA, SR422332199WA, SR422332200WA, SR422332201WA, SR422332202WA, SR422332203WA, SR422332204WA, SR422332205WA, SR422332206WA, SR422332207WA, SR422332208WA, SR422332210WA, SR422332209WA, SR422332211WA, SR422332212WA, SR422332213WA, SR422332214WA, SR422332215WA, SR422332216WA, SR422332217WA, SR422332218WA, SR422332219WA, SR422332220WA, SR422332221WA, SR422332222WA, SR422332223WA, SR422332224WA, SR422332225WA, SR422332226WA, SR422332227WA, SR422332228WA, SR422332229WA, SR422332230WA, SR422332251WA, SR422332252WA, SR422332253WA, SR422332254WA, SR422332255WA, SR422332256WA, SR422332257WA, SR422332258WA, SR422332259WA, SR422332263WA, SR422332260WA, SR422332261WA, SR422332262WA, SR422332128WA, SR422332124WA, SR422332125WA, SR422332126WA, SR422332130WA, SR422332131WA, SR422332132WA, SR422332133WA, SR422332134WA, SR422332138WA, SR422332267WA, SR422332264WA, SR422332265WA, SR422332266WA, SR422332268WA, SR422332269WA, SR422332270WA, SR422332271WA, SR422332272WA, SR422332273WA, SR422332274WA, SR422332142WA, SR422332139WA, SR422332140WA, SR422332141WA, SR422332143WA, SR422332144WA, SR422332145WA, SR422332149WA, SR422332146WA, SR422332147WA, SR422332148WA, SR422332150WA, SR422332151WA, SR422332152WA, SR422332153WA, SR422332154WA, SR422332155WA, SR422332156WA, SR422332157WA, SR422332158WA, SR422332159WA, SR422332160WA, SR422332161WA, SR422332162WA, SR422332163WA, SR422332164WA, SR422332165WA, SR422332166WA, SR422332167WA, SR422332168WA, SR422332169WA, SR422332170WA, SR422332171WA, SR422332172WA, SR422332173WA; Model Number 6160000-001-100728, Serial Numbers: SR422231017PA, SR422231019PA, SR422231020PA, SR422231021PA, SR422231023PA, SR422241005PA, SR422241002PA, SR422231038PA, SR422241001PA, SR422241003PA, SR422241004PA, SR422231018PA, SR422231028PA, SR422231024PA, SR422231025PA, SR422231027PA, SR422231029PA, SR422231035PA, SR422231036PA, SR422231014PA, SR422231012PA, SR422231013PA, SR422231015PA, SR422231016PA, SR422231033PA, SR422231037PA, SR422231032PA, SR422231034PA, SR422231030PA, SR422231031PA, SR422231026PA, SR422231011PA, SR422231010PA, SR422231009PA, SR422231005PA, SR422231007PA, SR422231008PA, SR422231006PA; Model Number 6160000-001-726232, Serial Numbers: SR420510001WA; Model Number 6160000-001-726248, Serial Numbers: SR420510002WA; Model Number 6160000-001-737890, Serial Numbers: SR421040002WA, SR421050008WA, SR421050009WA, SR421060001WA, SR421060003WA, SR421070001WA, SR421060004WA, SR421050005WA, SR421050006WA, SR421050007WA, SR421060002WA; Model Number 6160000-001-765412, Serial Numbers: SR421100001WA; Model Number 6160000-001-767955, Serial Numbers: SR421070002WA; Model Number 6160000-001-771434, Serial Numbers: SR421120092WA, SR421120089WA, SR421120090WA, SR421120091WA, SR421120093WA, SR421120094WA, SR421120095WA, SR421120096WA, SR421120097WA, SR421120098WA, SR421120099WA, SR421120100WA, SR421120101WA, SR421120102WA, SR421120103WA; Model Number 6160000-001-787700, Serial Numbers: SR421300005WA, SR421150017WA, SR421150014WA, SR421150016WA, SR421250062WA, SR421250059WA, SR421250060WA, SR421250061WA, SR421250063WA, SR421250064WA, SR421250065WA, SR421250066WA, SR421250067WA, SR421250068WA, SR421250069WA, SR421430007WA, SR421430008WA, SR421430006WA, SR421430005WA, SR421440002WA, SR421440001WA, SR421150012WA, SR421150010WA, SR421150011WA, SR421150005WA, SR421150006WA, SR421150007WA, SR421150008WA, SR421150009WA, SR421472004WA, SR421472009WA, SR421472010WA, SR421472001WA, SR421472003WA, SR421472005WA, SR421472006WA, SR421472007WA, SR421472008WA, SR421390019WA, SR421390021WA, SR422152004WA, SR422152001WA, SR422152002WA, SR422152003WA, SR422152005WA, SR422152006WA, SR422152007WA, SR422152008WA, SR422152009WA, SR422152010WA, SR422152011WA, SR422152012WA, SR422152013WA, SR422152015WA, SR422152014WA, SR421430009WA, SR421452037WA, SR421452038WA, SR421502010WA, SR421502007WA, SR421502008WA, SR421502009WA, SR421502011WA, SR421502012WA, SR421502057WA, SR421502054WA, SR421502055WA, SR421502056WA, SR421502058WA, SR421502059WA, SR421502060WA, SR421502061WA, SR421502062WA, SR421502063WA, SR421502064WA, SR421502065WA, SR421502066WA, SR421502069WA, SR421502068WA, SR421150015WA, SR421300004WA, SR421300003WA, SR421300006WA, SR421390020WA, SR421390017WA, SR421390018WA, SR421502067WA, SR421472002WA, SR421170045WA, SR421482043WA; Model Number 6160000-001-788679, Serial Numbers: SR421130122WA, SR421130120WA, SR421130121WA, SR421130123WA, SR421130124WA, SR421130125WA, SR421130126WA, SR421130127WA, SR421130128WA, SR421130129WA, SR421130130WA, SR421130131WA, SR421130132WA, SR421130133WA, SR421160001WA, SR421160026WA, SR421200053WA, SR421482020WA, SR421482021WA, SR421482022WA, SR421482023WA, SR421482024WA, SR421482025WA, SR421482026WA, SR421482027WA, SR421130112WA, SR422032010WA, SR421130113WA, SR421130115WA, SR421160053WA, SR421160050WA, SR421160051WA, SR421160052WA, SR421160045WA, SR421160046WA, SR421160047WA, SR421160048WA, SR421160049WA, SR421410057WA, SR421482038WA, SR421482039WA, SR421482040WA, SR421482041WA, SR421482042WA, SR421260007WA, SR421260008WA, SR421260009WA, SR421410062WA, SR421260038WA, SR421260037WA, SR421260039WA, SR421260040WA, SR421260041WA, SR421260042WA, SR421260043WA, SR421260044WA, SR421260045WA, SR421260046WA, SR421260047WA, SR421260048WA, SR421370076WA, SR421370086WA, SR421410061WA, SR421420081WA, SR421130111WA, SR421420078WA, SR421420077WA, SR421160044WA, SR421160041WA, SR421160042WA, SR421160043WA, SR421160039WA, SR421160037WA, SR421160038WA, SR421160040WA, SR421410051WA, SR421200004WA, SR421200005WA, SR421200006WA, SR421420065WA, SR422032011WA, SR421260006WA, SR421160004WA, SR421160002WA, SR421160005WA, SR421160006WA, SR421260010WA, SR421260011WA, SR421260013WA, SR421260014WA, SR421420066WA, SR421420070WA, SR421420071WA, SR421420072WA, SR421420073WA, SR421420074WA, SR421420075WA, SR421420076WA, SR422032007WA, SR422032005WA, SR422032006WA, SR422032008WA, SR421370078WA, SR421420067WA, SR421420068WA, SR421420079WA, SR421420069WA, SR421160003WA, SR421260003WA, SR421260004WA, SR421370065WA, SR421370063WA, SR421370064WA, SR421370066WA, SR421370067WA, SR421370068WA, SR421370069WA, SR421370070WA, SR421370071WA, SR421370072WA, SR421370079WA, SR421370080WA, SR421370084WA, SR421370081WA, SR421370082WA, SR421370083WA, SR421420082WA, SR421420083WA, SR421420084WA, SR421420085WA, SR421482018WA, SR421482019WA, SR421260012WA, SR421160032WA, SR421160034WA, SR421160035WA, SR421160036WA, SR421160033WA, SR422032004WA, SR421260035WA, SR421260036WA, SR421260032WA, SR421260033WA, SR421260034WA, SR421200042WA, SR421200043WA, SR421200044WA, SR421200045WA, SR421200046WA, SR421200047WA, SR421200051WA, SR421200048WA, SR421200049WA, SR421200050WA, SR421482033WA, SR421482032WA, SR421482034WA, SR421482035WA, SR421482036WA, SR421482037WA, SR421200052WA, SR421160012WA, SR421160013WA, SR421160014WA, SR421370085WA, SR421130109WA, SR421130110WA, SR421160031WA, SR421160028WA, SR421160029WA, SR421160030WA, SR421160027WA, SR421200007WA, SR421200008WA, SR421200009WA, SR421200010WA, SR421200011WA, SR421200012WA, SR421200013WA, SR421200014WA, SR421200015WA, SR421200016WA, SR421200017WA, SR421200018WA, SR421200019WA, SR421200020WA, SR421200021WA, SR421200022WA, SR421200023WA, SR421200027WA, SR421200024WA, SR421200025WA, SR421200026WA, SR421200028WA, SR421200029WA, SR421200033WA, SR421200030WA, SR421200031WA, SR421200032WA, SR421200037WA, SR421200034WA, SR421200035WA, SR421200036WA, SR421200038WA, SR421200039WA, SR421200040WA, SR421200041WA, SR421420064WA, SR421410053WA, SR421120059WA, SR421120056WA, SR421120057WA, SR421120058WA, SR421120060WA, SR421120061WA, SR421120062WA, SR421120063WA, SR421120064WA, SR421120065WA, SR421120066WA, SR421120067WA, SR421120068WA, SR421120069WA, SR421120070WA, SR421120071WA, SR421120072WA, SR421130106WA, SR421120073WA, SR421130104WA, SR421130105WA, SR421130107WA, SR421130108WA, SR421120054WA, SR421120055WA, SR421160054WA, SR421160055WA, SR421410054WA, SR421370075WA, SR421130117WA, SR421410055WA, SR421410056WA, SR421130118WA, SR421260049WA, SR421260050WA, SR421260051WA, SR421260052WA, SR421410059WA, SR421130119WA, SR421410060WA, SR421160015WA, SR421160016WA, SR421160017WA, SR421160023WA, SR421160024WA, SR421160025WA, SR421370077WA, SR421370062WA, SR421260015WA, SR421482029WA, SR421482030WA, SR421482031WA, SR421370073WA, SR421370074WA, SR421420080WA, SR421160007WA, SR421160008WA, SR421160009WA, SR421160010WA, SR421160011WA, SR421260005WA, SR421410052WA, SR422032012WA, SR422032013WA, SR422032014WA, SR422032015WA, SR422032016WA, SR422032017WA, SR422032018WA, SR422032022WA, SR422032019WA, SR422032020WA, SR422032021WA, SR422032026WA, SR422032023WA, SR422032024WA, SR422032025WA, SR422032027WA, SR422032028WA, SR421130114WA, SR421410058WA, SR421482028WA, SR421410063WA, SR422032009WA, SR421130116WA, SR421260024WA, SR421260025WA, SR421260026WA, SR421260027WA, SR421260028WA, SR421260016WA, SR421260017WA, SR421260018WA, SR421260019WA, SR421260020WA, SR421260021WA, SR421260022WA, SR421260023WA, SR421260029WA, SR421260030WA, SR421260031WA; Model Number 6160000-001-791943, Serial Numbers: SR421240058WA, SR421160018WA, SR421160020WA, SR421160019WA; Model Number 6160000-001-794786, Serial Numbers: SR421230004WA, SR421230001WA, SR421230002WA, SR421230003WA, SR421230005WA, SR421230006WA, SR421230007WA, SR421230008WA, SR421230009WA, SR421230010WA, SR421230011WA, SR421230012WA, SR421230013WA, SR421230014WA, SR421230015WA, SR421230016WA, SR421230017WA, SR421230018WA, SR421230019WA, SR421230020WA, SR421250058WA, SR421250057WA, SR421250051WA; Model Number 6160000-001-799233, Serial Numbers: SR421150001WA; Model Number 6160000-001-802266, Serial Numbers: SR421220010WA, SR421220011WA, SR421472093WA, SR421472094WA; Model Number 6160000-001-803246, Serial Numbers: SR421160022WA; Model Number 6160000-001-830726, Serial Numbers: SR421260060WA, SR421260061WA, SR421260062WA, SR421260063WA; Model Number 6160000-001-839141, Serial Numbers: SR421260002WA; Model Number 6160000-001-848493, Serial Numbers: SR421280010WA; Model Number 6160000-001-848921, Serial Numbers: SR421280007WA, SR421280008WA, SR421280009WA; Model Number 6160000-001-861261, Serial Numbers: SR421380006WA, SR421380007WA; Model Number 6160000-001-906100, Serial Numbers: SR421440015WA, SR421440016WA, SR421452002WA, SR421452003WA, SR421452004WA, SR421452005WA, SR421452006WA, SR421452007WA, SR421452009WA, SR421452010WA, SR421452011WA, SR421452012WA, SR421452014WA, SR421452015WA, SR421452016WA, SR421440007WA, SR421440008WA, SR421440009WA, SR421440010WA, SR421440011WA, SR421440012WA, SR421440013WA, SR421440014WA, SR421452001WA, SR421452008WA, SR421452013WA; Model Number 6160000-001-906386, Serial Numbers: SR421472011WA; Model Number 6160000-001-925411, Serial Numbers: SR422352045WA; Model Number 6160000-001-928665, Serial Numbers: SR421472013WA, SR421472012WA; Model Number 6160000-001-954478, Serial Numbers: SR422112038WA, SR422112035WA, SR422112036WA, SR422112037WA, SR422112039WA, SR422112040WA, SR422112041WA, SR422112042WA, SR422112043WA, SR422112044WA, SR422382004WA, SR422382005WA, SR422382006WA, SR422382007WA, SR422382008WA, SR422382009WA, SR422382010WA, SR422382011WA, SR422382012WA, SR422382013WA, SR422382014WA, SR422382015WA, SR422382016WA, SR422382017WA, SR422382018WA, SR422382019WA, SR422382020WA, SR422382003WA, SR422382001WA, SR422382002WA.
• Recalling Firm/ Manufacturer: GE Medical Systems, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• Manufacturer Reason for Recall: 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 Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 826 devices
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MHX