Carestation 620 A1…

Date

July 19, 2017

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

Reason

Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction

Distribution pattern

US Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL GA, ID,IL, IN, KY, LA, , MA, MD, MI, MO, MS, MT, MN, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI, and UT. OUS: Algeria Argentina Australia Austria Belgium Bolivia Bosnia and Herzegovina Brazil Bulgaria Cambodia Canada Chile Colombia Costa Rica Cote d'Ivoire Croatia Czech Republic Ecuador Egypt El Salvador Estonia Finland France Germany Greece Honduras Hong Kong Hungary India Indonesia Iraq Ireland Israel Italy Japan Jordan Kenya Korea (Republic Of) Kuwait Latvia Lebanon Lithuania Malaysia Maldives Malta Mauritius Mexico Moldova Morocco Myanmar Netherlands New Zealand Nigeria Norway Oman Pakistan Paraguay Peru Philippines Poland Portugal Romania Russia Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Tanzania Thailand Turkey United Arab Emirates United Kingdom Uruguay Vietnam Zimbabwe

Quantity

3,448 (334 US; 3,114 OUS)

Codes and lots

Carestation 620 A1: SM616460036MA SM616460037MA SM616400001MA SM616250007MA SM616340023MA SM616460048MA SM616460049MA SM616460022MA SM616250005MA SM616400004MA SM616400005MA SM617110011MA SM617110012MA SM617110013MA SM617110014MA SM616430024MA SM616200020MA SM616200019MA SM616200021MA SM616200022MA SM616200023MA SM616200024MA SM617010108MA SM616270021MA SM616270022MA SM617020019MA SM617020020MA SM617020021MA SM616460047MA SM616340001MA SM616340002MA SM616340039MA SM616340025MA SM616460052MA SM616460053MA SM616460054MA SM616460055MA SM616460056MA SM616460057MA SM616250006MA SM616460035MA SM617010114MA SM617010115MA SM617010116MA SM617010117MA SM617010118MA SM616340027MA SM616410061MA SM616340018MA SM616340019MA SM616340020MA SM616460030MA SM616460028MA SM616460029MA SM616410043MA SM617020010MA SM617020011MA SM617020012MA SM617020013MA SM617020014MA SM617020015MA SM617020016MA SM617020017MA SM617020018MA SM617060084MA SM617100056MA SM617100057MA SM616400016MA SM616400017MA SM616170021MA SM616170022MA SM616200012MA SM616340028MA SM616340029MA SM616340030MA SM617100058MA SM616340021MA SM616430034MA SM616430035MA SM617100157MA SM616250001MA SM616250002MA SM616250003MA SM616250004MA SM617100019MA SM617100020MA SM617100021MA SM617100022MA SM617100023MA SM617100024MA SM617100025MA SM617020026MA SM616100020MA SM616100021MA SM616100022MA SM616100023MA SM616100024MA SM616200013MA SM616200016MA SM616200014MA SM616200015MA SM617020007MA SM617020008MA SM617020009MA SM615500007WA SM616150007WA SM616220004WA SM616220005WA SM616220006WA SM616370002WA SM616370003WA SM616370005WA SM616370006WA SM616450003WA SM617030015WA SM617030016WA SM617030017WA SM617040018WA SM617040019WA SM617040020WA SM617040021WA SM617040022WA SM617040023WA SM617060001WA SM617060002WA SM617060003WA SM617060004WA SM617120006WA SM617120007WA SM617080015WA SM617080016WA SM617080017WA SM617080018WA SM617080019WA SM617080020WA SM617080021WA SM617080022WA SM616400019MA SM616400020MA SM616460023MA SM616460024MA SM616460025MA SM616460026MA SM616460027MA SM617050039MA SM616330011WA SM616330012WA SM617040001WA SM615520001WA SM615520002WA SM615520003WA SM616240002WA SM616340049WA SM616340050WA SM616240001WA SM615390002WA SM615390003WA SM615390004WA SM616430045WA SM616430046WA SM616270025WA SM616270026WA SM616220009WA SM616220010WA SM616220011WA SM616340043WA SM615430004WA SM616140005WA SM616140006WA SM616280020WA SM616280021WA SM615390001WA SM616330002WA SM616330003WA SM616330004WA SM616280005WA SM616280006WA SM616280007WA SM616280008WA SM616280009WA SM616280010WA SM616280011WA SM616280012WA SM616280013WA SM616280014WA SM616280015WA SM616280016WA SM616280017WA SM616280018WA SM616280019WA SM616400021WA SM616400022WA SM616400023WA SM616190005WA SM615500005WA SM616210004WA SM616460005WA SM616460006WA SM616460007WA SM616460008WA SM616460009WA SM616320002MA SM616320003MA SM616410012MA SM616410013MA SM616410014MA SM616440003WA SM616500002WA SM616500003WA SM616500004WA SM616510001WA SM616510002WA SM616510003WA SM616510004WA SM616170018WA SM616290001WA SM616030001WA SM616030002WA SM616030003WA SM616030004WA SM616030005WA SM616170007WA SM616440006WA SM616170008WA SM616150014WA SM616350001WA SM616350003WA SM616410025WA SM616410026WA SM617030018WA SM617030019WA SM617030020WA SM617030021WA SM617030022WA SM617030023WA SM617030024WA SM616150013WA SM616290002WA SM616290003WA SM616290004WA SM616290005WA SM616290006WA SM616150010WA SM616170010WA SM616170011WA SM616170012WA SM616170013WA SM616410031WA SM616410039WA SM616410040WA SM616150011WA SM616150012WA SM617040011WA SM617040013WA SM616290007WA SM616350004WA SM616410002WA SM616410023WA SM616410027WA SM616410028WA SM616410029WA SM616410036WA SM616420001WA SM616430041WA SM616430060WA SM616500001WA SM616510005WA SM616510006WA SM616510007WA SM616510008WA SM616510009WA SM616510010WA SM617010120WA SM617010121WA SM617010122WA SM617010123WA SM617030038WA SM617030039WA SM617080001WA SM617080002WA SM617080003WA SM616160007WA SM616160008WA SM617030033WA SM617030034WA SM616290008WA SM616410037WA SM616420002WA SM616150015WA SM616160005WA SM616160006WA SM616020006WA SM616020007WA SM616020008WA SM616410030WA SM616410035WA SM616290015WA SM616290016WA SM616290017WA SM616290019WA SM616290020WA SM616330015WA SM616330016WA SM615490002WA SM615490003WA SM615490007WA SM615490008WA SM615490009WA SM615490011WA SM616020009WA SM616020010WA SM616020012WA SM616170006WA SM616170016WA SM616430052WA SM616430053WA SM616430054WA SM616430055WA SM616430056WA SM616430057WA SM616430058WA SM616430059WA SM616430062WA SM615500002WA SM616050005WA SM616170019WA SM616170020WA SM616430061WA SM616350002WA SM616410024WA SM616300005WA SM616300006WA SM616330005WA SM616430063WA SM616430064WA SM617060140WA SM616440001WA SM616440002WA SM616020011WA SM616170014WA SM617040008WA SM616410038WA SM616020003WA SM616410033WA SM616410034WA SM617040014WA SM617040016WA SM617040017WA SM616430051WA SM616510011WA SM617020028WA SM617020029WA SM617020030WA SM617020031WA SM617020032WA SM617020033WA SM617020034WA SM617030025WA SM617030026WA SM617030027WA SM617030028WA SM617030029WA SM617030030WA SM617030031WA SM617030032WA SM617030037WA SM617030040WA SM617040009WA SM617040010WA SM617040012WA SM617040015WA SM617060128WA SM617060129WA SM617060130WA SM617060131WA SM617060132WA SM617060133WA SM617060134WA SM617060135WA SM617060136WA SM617060137WA SM617060138WA SM617060139WA SM617070010WA SM617070011WA SM617070012WA SM617070013WA SM617070014WA SM617070015WA SM617070016WA SM617070017WA SM617070018WA SM617070019WA SM617070020WA SM617070021WA SM617070023WA SM617070024WA SM617070025WA SM617070026WA SM617070027WA SM617070028WA SM617070029WA SM617070030WA SM617070031WA SM617070032WA SM617070033WA SM617070034WA SM617070035WA SM617070036WA SM617070037WA SM617070038WA SM617070039WA SM617070040WA SM617070041WA SM617070042WA SM617070043WA SM617070044WA SM617070045WA SM617070046WA SM617070047WA SM617070048WA SM617070049WA SM617080004WA SM617080005WA SM617080006WA SM617080007WA SM617080008WA SM617080009WA SM617080010WA SM617080011WA SM617080012WA SM617080013WA SM617080014WA SM617080023WA SM617080024WA SM617080025WA SM617080026WA SM617080027WA SM617080028WA SM617080029WA SM617080030WA SM617080031WA SM617090020WA SM617090021WA SM617090022WA SM617090023WA SM617090024WA SM617090025WA SM617090026WA SM617090027WA SM617090028WA SM617090029WA SM617090030WA SM617090031WA SM616170009WA SM616290018WA SM615500003WA SM616440005WA SM617030035WA SM617030036WA SM616020004WA SM616440004WA SM617020001WA SM617020002WA SM617020003WA SM617020004WA SM617020005WA SM616160003WA SM616160004WA SM616330013WA SM616330014WA SM617100026MA SM617100027MA SM616430026MA SM616200018MA SM616430025MA SM617100155MA SM617100018MA SM616310012MA SM616310029MA SM616140003WA SM616140004WA SM616280022MA SM616280023MA SM616280024MA SM616280025MA SM616400007MA SM616400008MA SM616400009MA SM616400010MA SM616400011MA SM617010109MA SM617010110MA SM617010111MA SM617010112MA SM617010113MA SM617100158MA SM617100159MA SM617100160MA SM616050004WA SM616070003WA SM616170001WA SM616170003WA SM616170005WA SM617010124WA SM617010125WA SM617010126WA SM617010127WA SM617010128WA SM617010132WA SM617010133WA SM617010134WA SM617010135WA SM617060126WA SM617060127WA SM616340014MA SM616340015MA SM616340016MA SM616400018MA SM616410044MA SM616410045MA SM616410046MA SM616410047MA SM617010106MA SM617010107MA SM617010119MA SM617100151MA SM617100152MA SM616150001WA SM616410032WA SM616270002WA SM617040004WA SM617020022MA SM617020023MA SM616100005MA SM616100006MA SM617060098MA SM617060099MA SM617060100MA SM616280028MA SM616280029MA SM616280030MA SM616280031MA SM616300009MA SM616300010MA SM616300011MA SM616300012MA SM616300014MA SM616300015MA SM616300016MA SM616300017MA SM616300018MA SM616310001MA SM616310002MA SM616310003MA SM616310004MA SM616310005MA SM616310006MA SM616310007MA SM616310008MA SM616310009MA SM616310010MA SM616310011MA SM617050009MA SM617050010MA SM617050011MA SM617050012MA SM617050013MA SM617050014MA SM617050015MA SM617050016MA SM617050017MA SM617050018MA SM617050019MA SM617050020MA SM617050021MA SM617050022MA SM617050023MA SM617050024MA SM617050025MA SM617050026MA SM617050027MA SM617050028MA SM617050029MA SM617050030MA SM617050031MA SM617050032MA SM617050033MA SM617050034MA SM617050035MA SM617050036MA SM617050037MA SM617050038MA SM617060006MA SM617060007MA SM617060008MA SM617060009MA SM617060010MA SM617060011MA SM617060012MA SM617060013MA SM617060014MA SM617060015MA SM617060016MA SM617060017MA SM617060018MA SM617060019MA SM617060020MA SM617060021MA SM617060022MA SM617060023MA SM617060024MA SM617060025MA SM617060026MA SM617060027MA SM617060028MA SM617060029MA SM617060030MA SM617060031MA SM617060032MA SM617060033MA SM617060034MA SM617060035MA SM617060039MA SM617060040MA SM617060041MA SM617060042MA SM617060043MA SM617060044MA SM617060045MA SM617060046MA SM617060047MA SM617060048MA SM617060049MA SM617060050MA SM617060051MA SM617060052MA SM617060053MA SM617060054MA SM617060055MA SM617060056MA SM617060057MA SM617060058MA SM617060059MA SM617060060MA SM617060061MA SM617060062MA SM617060063MA SM617060064MA SM617060065MA SM617060066MA SM617060067MA SM617060068MA SM617060069MA SM617060070MA SM617060071MA SM617060072MA SM617060073MA SM617060074MA SM617060075MA SM617060076MA SM617060077MA SM617060078MA SM617060079MA SM617060080MA SM617060081MA SM617060082MA SM617060083MA SM617100028MA SM617100029MA SM617100030MA SM617100031MA SM617100032MA SM617100033MA SM617100034MA SM617100035MA SM617100036MA SM617100037MA SM617100038MA SM617100039MA SM617100040MA SM617100041MA SM617100042MA SM617100043MA SM617100044MA SM617100045MA SM617100046MA SM617100047MA SM617100048MA SM617100049MA SM617100050MA SM617100051MA SM617100052MA SM617100053MA SM617100054MA SM617100055MA SM617100071MA SM617100072MA SM617100073MA SM617100074MA SM617100075MA SM617100076MA SM617100077MA SM617100078MA SM617100079MA SM617100080MA SM617100081MA SM617100082MA SM617100083MA SM617100084MA SM617100085MA SM617100086MA SM617100087MA SM617100088MA SM617100089MA SM617100090MA SM617100091MA SM617100092MA SM617100093MA SM617100094MA SM617100095MA SM617100096MA SM617100097MA SM617100098MA SM617100099MA SM617100100MA SM617100101MA SM617100102MA SM617100103MA SM617100104MA SM617100105MA SM617100106MA SM617100107MA SM617100108MA SM617100109MA SM617100110MA SM617100111MA SM617100112MA SM617100113MA SM617100114MA SM617100115MA SM617100116MA SM617100117MA SM617100118MA SM617100119MA SM617100120MA SM617100121MA SM617100122MA SM617100123MA SM617100124MA SM617100125MA SM617100126MA SM617100127MA SM617100128MA SM617100131MA SM617100132MA SM616400012MA SM616400013MA SM615500008WA SM616480018WA SM616480019WA SM616450006WA SM616320024WA SM617020035WA SM617020036WA SM615030014WA SM616340022MA SM616410056MA SM616410057MA SM616460031MA SM616460032MA SM616460033MA SM616460034MA SM616400014MA SM616280032WA SM617110001WA SM617110002WA SM617110003WA SM615370001WA SM616440025WA SM616100033WA SM615350082WA SM615350083WA SM615350084WA SM615350085WA SM615370003WA SM615370020WA SM615370021WA SM615370018WA SM615370019WA SM616430042WA SM616430044WA SM615440001WA SM615350088WA SM615350089WA SM617110009WA SM616200002WA SM615440003WA SM616210001WA SM616210002WA SM616210003WA SM617030011WA SM617040005WA SM617040006WA SM617100069WA SM615510004WA SM615510005WA SM615510006WA SM616220020WA SM616220019WA SM616360005WA SM615370022WA SM615500004WA SM615500009WA SM615510001WA SM615510002WA SM616190014WA SM616190016WA SM616220007WA SM616220008WA SM616220012WA SM616220013WA SM616360022WA SM616440024WA SM616220001WA SM617070009WA SM617100014WA SM615510003WA SM616340044WA SM615370006WA SM615370008WA SM615370010WA SM615370011WA SM615370012WA SM615370005WA SM616370001WA SM616220021WA SM616220022WA SM616220025WA SM616240005WA SM616240006WA SM616320022WA SM616320023WA SM616430043WA SM615340070WA SM615370009WA SM615430001WA SM615370007WA SM616220023WA SM616220024WA SM615360005WA SM615440002WA SM616100038WA SM616150004WA SM616150005WA…

Recall started

May 2, 2017

Device type

Gas-Machine, Anesthesia

Root cause (FDA)

Device Design

What the company told customers

Consignees were sent on 5/2/2017 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 34082 dated May 2, 2017. The letter was addressed to Chief of Anesthesia, Director of Biomedical / Clinical Engineering & Health Care Administrator / Risk Manager. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. GE Healthcare will correct affected products. GE Healthcare representative will contact the firms to arrange for the correction. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recall number

Z-2703-2017

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2703-2017. The agency record governs; check it and the company before acting.