GE Healthcare…

Date

July 30, 2014

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

GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

Reason

Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the system may experience a sound loss including alarm sounds from the patient monitor. This may occur if the external display is powered off and on during normal operation of the monitor.

Distribution pattern

Worldwide distribution. US nationwide including Puerto Rico, ZAMBIA, YEMEN, VIETNAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, UNITED REPUBLIC OF TANZANIA, TAJIKISTAN, TAIWAN, SYRIA, SWITZERLAND, SWEDEN, SRILANKA, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN F¿D¿RATION, ROMANIA, QATAR, PORTUGAL, POLAND, PHILIPPINES, PERU, PARAGUAY, PANAMA, PAKISTAN, OMAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLAND, NAMIBIA, MYANMAR, MOROCCO, MEXICO, MAURITIUS, MALAYSIA, LITHUANIA, LIBYAN ARAB JAMAHIRIYA, LEBANON, LATVIA, KUWAIT, REPUBLIC OF KOREA, KAZAKHSTAN, JORDAN, Italy, JAPAN, JAMAICA, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, HONDURAS, GUATEMALA, GREECE, GERMANY, GEORGIA, FRANCE, FINLAND, ESTONIA, EL SALVADOR, Egypt, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, COSTA RICA, COLOMBIA, CHINA, CHILE, CANADA, BULGARIA, BRUNEI, BRAZIL, BOLIVIA, BERMUDA, BELGIUM, BANGLADESH, BAHRAIN, BAHAMAS, AZERBAIJAN, AUSTRIA, AUSTRALIA, ARGENTINA.

Quantity

21,799 (7,635 units US, 14,164 units OUS)

Codes and lots

Mfg Lot or Serial # System ID SEW10233202HA M1176021-052037 SEW10233203HA M1176021 SEW10233204HA M1176021-052037 SEW10233206HA M1176021-052037 SEW10233209HA M1176021-052037 SEW10233210HA M1176021-052037 SEW10243447HA M1176021-052037 SEW10243449HA M1176021-052037 SEW10243450HA M1176021-052037 SEW10243458HA M1176021-052037 SEW10243476HA M1176021-052037 SEW10243477HA M1176021-052037 SEW10243478HA M1176021-052037 SEW10243479HA M1176021-052037 SEW10243481HA M1176021-052037 SEW10243482HA M1176021-052037 SEW10243484HA M1176021-052037 SEW10243486HA M1176021-052037 SEW10243487HA M1176021-052037 SEW10243489HA M1176021-052037 SEW10243490HA M1176021-052037 SEW10243491HA M1176021-052037 SEW10243492HA M1176021-052037 SEW10243496HA M1176021-052037 SEW10243499HA M1176021-052037 SEW10243500HA M1176021-052037 SEW10243503HA M1176021-052037 SEW10243504HA M1176021-052037 SEW10354687HA M1176021 SEW10354688HA M1176021 SEW10354694HA M1176021-052037 SEW10354695HA M1176021-052037 SEW10354696HA M1176021-052037 SEW10354697HA M1176021-052037 SEW10354701HA M1176021-052037 SEW10354704HA M1176021 SEW10354706HA M1176021-052037 SEW10354707HA M1176021-052037 SEW10354708HA M1176021-052037 SEW10354709HA M1176021-052037 SEW10354712HA M1176021-052037 SEW10354713HA M1176021-052037 SEW10354717HA M1176021 SEW10354722HA M1176021-052037 SEW10354724HA M1176021-052037 SEW10354728HA M1176021-052037 SEW10354730HA M1176021-052037 SEW10354736HA M1176021-052037 SEW10354738HA M1176021 SEW10354740HA M1176021-052037 SEW10354741HA M1176021-052037 SEW10354746HA M1176021-052037 SEW10354749HA M1176021-052037 SEW10354751HA M1176021-052037 SEW10354752HA M1176021-052037 SEW10354754HA M1176021-052037 SEW10354756HA M1176021-052037 SEW10354757HA M1176021-052037 SEW10354758HA M1176021-052037 SEW10354759HA M1176021-052037 SEW10354760HA M1176021-052037 SEW10354761HA M1176021-052037 SEW10354762HA M1176021-052037 SEW10354763HA M1176021-052037 SEW10354764HA M1176021-052037 SEW10354767HA M1176021-052037 SEW10354768HA M1176021-052037 SEW10354773HA M1176021-052037 SEW10354774HA M1176021-052037 SEW10354775HA M1176021-052037 SEW10354776HA M1176021-052037 SEW10354777HA M1176021-052037 SEW10354778HA M1176021-052037 SEW10354780HA M1176021-052037 SEW10354781HA M1176021-052037 SEW10354783HA M1176021-052037 SEW10354784HA M1176021-052037 SEW10385221HA M1176021-052037 SEW10385223HA M1176021 SEW10385225HA M1176021 SEW10385226HA M1176021 SEW10385227HA M1176021 SEW10385228HA M1176021 SEW10385230HA M1176021-052037 SEW10385231HA M1176021-052037 SEW10385232HA M1176021-052037 SEW10385234HA M1176021-052037 SEW10385236HA M1176021 SEW10385256HA M1176021-052037 SEW10393672HA M1176021-062897 SEW10393675HA M1176021-062897 SEW10393682HA M1176021-062897 SEW10393747HA M1176021-079419 SEW10405542HA M1176021-069222 SEW10405618HA M1176021-079419 SEW10405648HA M1205643-088364 SEW10405669HA M1176021-062897 SEW10405670HA M1176021-062897 SEW10405673HA M1176021-062897 SEW10405696HA M1176021-062897 SEW10446451HA M1176021-079419 SEW10446466HA M1205643-101584 SEW10456855HA M1176021-103880 SEW10467083HA M1205643-088364 SEW10467133HA M1176021-062897 SEW10467151HA M1176021-062897 SEW10467216HA M1176021-062897 SEW10467289HA M1176021-103880 SEW10517983HA M1176021-067875 SEW10528081HA M1176021-067875 SEW10528111HA M1176021-067875 SEW11018531HA M1176021-067875 SEW11018538HA M1176021-067875 SEW11018545HA M1176021-067875 SEW11018644HA M1176021-067875 SEW11018645HA M1176021-067875 SEW11018646HA M1176021-067875 SEW11018647HA M1176021-067875 SEW11018650HA M1176021-067875 SEW11018651HA M1176021-067875 SEW11018652HA M1176021-067875 SEW11018653HA M1176021-067875 SEW11018702HA M1176021-067875 SEW11018721HA M1176021-067875 SEW11018725HA M1176021-067875 SEW11018729HA M1176021-067875 SEW11018730HA M1176021-067875 SEW11018731HA M1176021-067875 SEW11018732HA M1176021-067875 SEW11038851HA M1176021-067875 SEW11038910HA M1176021-078234 SEW11038918HA M1176021-067875 SEW11059070HA M1205643-088364 SEW11059082HA M1205643-088364 SEW11059083HA M1205643-088364 SEW11059084HA M1205643-088364 SEW11059128HA M1176021-067875 SEW11059129HA M1176021-067875 SEW11059130HA M1176021-067875 SEW11059131HA M1176021-067875 SEW11059132HA M1176021-067875 SEW11059133HA M1176021-067875 SEW11059134HA M1176021-067875 SEW11059135HA M1176021-067875 SEW11059136HA M1176021-067875 SEW11059137HA M1176021-067875 SEW11059138HA M1176021-080617 SEW11059139HA M1176021-085419 SEW11059140HA M1176021-085419 SEW11059141HA M1176021-085419 SEW11059142HA M1176021-052037 SEW11059143HA M1176021-085419 SEW11059144HA M1176021-085419 SEW11059145HA M1176021-077889 SEW11059148HA M1176021-052037 SEW11059149HA M1176021-078234 SEW11059150HA M1176021-052037 SEW11059151HA M1176021-062617 SEW11059153HA M1176021-052037 SEW11059155HA M1176021-062617 SEW11059156HA M1176021-062617 SEW11059157HA M1176021-052037 SEW11059158HA M1176021-052037 SEW11059159HA M1176021-052037 SEW11059160HA M1176021-052037 SEW11059161HA M1176021-052037 SEW11059164HA M1176021-052037 SEW11059165HA M1176021-052037 SEW11059166HA M1176021-062617 SEW11059168HA M1176021-052037 SEW11059169HA M1176021-052037 SEW11059171HA M1176021-052037 SEW11059172HA M1176021-071488 SEW11059173HA M1176021-052037 SEW11059174HA M1176021-052037 SEW11059175HA M1176021-052037 SEW11059177HA M1176021-062617 SEW11059178HA M1176021-062617 SEW11059179HA M1176021-069587 SEW11059180HA M1176021-062617 SEW11059181HA M1176021-062617 SEW11059182HA M1176021-062617 SEW11059183HA M1176021-062617 SEW11059184HA M1176021-052037 SEW11059185HA M1176021-062617 SEW11059186HA M1176021-062617 SEW11059187HA M1176021-071108 SEW11059188HA M1176021-052037 SEW11059189HA M1176021-052037 SEW11059190HA M1176021-062617 SEW11059191HA M1176021-052037 SEW11059192HA M1176021-052037 SEW11059193HA M1176021-052037 SEW11059194HA M1176021-052037 SEW11059198HA M1176021-071108 SEW11059200HA M1176021-069587 SEW11059202HA M1176021-071108 SEW11059204HA M1176021-077172 SEW11059206HA M1176021-071108 SEW11059208HA M1176021-069586 SEW11059212HA M1176021-077889 SEW11059213HA M1176021-068615 SEW11059215HA M1176021-077889 SEW11059216HA M1176021-071108 SEW11059217HA M1176021-085262 SEW11059218HA M1176021-085684 SEW11059219HA M1176021-077889 SEW11059220HA M1176021-071108 SEW11059221HA M1176021-062617 SEW11059226HA M1176021-077889 SEW11059227HA M1176021-077889 SEW11059233HA M1176021-077889 SEW11059234HA M1176021-085684 SEW11059235HA M1176021-068615 SEW11059236HA M1176021-069586 SEW11059242HA M1176021-069587 SEW11059243HA M1176021-075931 SEW11079351HA M1176021-069587 SEW11079352HA M1176021-062617 SEW11079353HA M1176021-073046 SEW11079354HA M1176021-062617 SEW11079355HA M1176021-085684 SEW11079357HA M1176021-066211 SEW11079358HA M1176021-062617 SEW11079359HA M1176021-062617 SEW11079360HA M1176021-052037 SEW11079361HA M1176021-062617 SEW11079363HA M1176021-069587 SEW11079365HA M1176021-068615 SEW11079366HA M1176021-071488 SEW11079367HA M1176021-085684 SEW11079368HA M1176021-071488 SEW11079369HA M1176021-052037 SEW11079370HA M1176021-052037 SEW11079371HA M1176021-068615 SEW11079372HA M1176021-052037 SEW11079373HA M1176021-077172 SEW11079375HA M1176021-068615 SEW11079376HA M1176021-052037 SEW11079377HA M1176021-077889 SEW11079378HA M1176021-077172 SEW11079379HA M1176021-085684 SEW11079380HA M1176021-085684 SEW11079381HA M1176021-077889 SEW11079382HA M1176021-068615 SEW11079383HA M1176021-085684 SEW11079384HA M1176021-068615 SEW11079387HA M1176021-066795 SEW11079392HA M1176021-069587 SEW11079394HA M1176021-073046 SEW11079396HA M1176021-077889 SEW11079408HA M1176021-066795 SEW11079415HA M1176021-069587 SEW11079417HA M1176021-069587 SEW11079418HA M1176021-069587 SEW11079419HA M1176021-077172 SEW11079420HA M1176021-066211 SEW11079421HA M1176021-069587 SEW11079422HA M1176021-069587 SEW11079423HA M1176021-069587 SEW11079424HA M1176021-068615 SEW11079425HA M1176021-077172 SEW11079426HA M1176021-083051 SEW11079427HA M1176021-066211 SEW11079428HA M1176021-071488 SEW11079429HA M1176021-066211 SEW11079430HA M1176021-069586 SEW11079431HA M1176021-052037 SEW11079433HA M1176021-071108 SEW11079436HA M1176021-077172 SEW11079441HA M1176021-077172 SEW11079450HA M1176021-071250 SEW11079451HA M1176021-069587 SEW11079453HA M1176021-071488 SEW11079456HA M1176021-071488 SEW11079458HA M1176021-066211 SEW11079459HA M1176021-071488 SEW11079462HA M1176021-066211 SEW11079463HA M1176021-077172 SEW11079464HA M1176021-071488 SEW11079465HA M1176021-077172 SEW11079466HA M1176021-077172 SEW11079467HA M1176021-066795 SEW11079468HA M1176021-066795 SEW11079469HA M1176021-077172 SEW11079470HA M1176021-069587 SEW11079471HA M1176021-069587 SEW11079472HA M1176021-066211 SEW11079473HA M1176021-069587 SEW11079474HA M1176021-069587 SEW11079475HA M1176021-066795 SEW11079476HA M1176021-066795 SEW11079477HA M1176021-069587 SEW11079478HA M1176021-069587 SEW11079479HA M1176021-077172 SEW11079481HA M1176021-068615 SEW11079484HA M1176021-069587 SEW11079486HA M1176021-066795 SEW11079487HA M1176021-069587 SEW11079488HA M1176021-066211 SEW11079489HA M1176021-071488 SEW11079490HA M1176021-069587 SEW11079491HA M1176021-066211 SEW11079493HA M1176021-077172 SEW11079495HA M1176021-071488 SEW11079496HA M1176021-077172 SEW11079501HA M1176021-066211 SEW11079504HA M1176021-061908 SEW11079505HA M1176021-073046 SEW11079507HA M1176021-077172 SEW11079509HA M1176021-077172 SEW11079510HA M1176021-052037 SEW11079511HA M1176021-077172 SEW11079512HA M1176021-077172 SEW11079513HA M1176021-052037 SEW11079515HA M1176021-069586 SEW11079519HA M1176021-066355 SEW11079521HA M1176021-073046 SEW11079524HA M1176021-073046 SEW11079526HA M1176021-073046 SEW11079528HA M1176021-052037 SEW11079529HA M1176021-052037 SEW11079532HA M1176021-066795 SEW11079533HA M1176021-077889 SEW11079534HA M1176021-077172 SEW11079535HA M1176021-071488 SEW11079536HA M1176021-066211 SEW11079537HA M1176021-066795 SEW11079538HA M1176021-066795 SEW11079540HA M1176021-066795 SEW11079541HA M1176021-073046 SEW11079545HA M1176021-066795 SEW11079546HA M1176021-066795 SEW11079547HA M1176021-071108 SEW11100001HA M1176021-078228 SEW11100003HA M1176021-077889 SEW11100004HA M1176021-052037 SEW11100008HA M1176021-077889 SEW11100009HA M1176021-078228 SEW11100010HA M1176021-062617 SEW11100011HA M1176021-078234 SEW11100012HA M1176021-052037 SEW11100013HA M1176021-052037 SEW11100014HA M1176021-077889 SEW11100015HA M1176021-077889 SEW11100016HA M1176021-077889 SEW11100017HA M1176021-052037 SEW11100021HA M1176021-065536 SEW11100022HA M1176021-065536 SEW11100023HA M1176021-078234 SEW11100024HA M1176021-073046 SEW11100025HA M1176021-078234 SEW11100026HA M1176021-065536 SEW11100027HA M1176021-065536 SEW11100028HA M1176021-065536 SEW11100029HA M1176021-078234 SEW11100030HA M1176021-077889 SEW11100032HA M1176021-077889 SEW11100033HA M1176021-065536 SEW11100034HA M1176021-065536 SEW11100035HA M1176021-077889 SEW11100036HA M1176021-065536 SEW11100037HA M1176021-077889 SEW11100039HA M1176021-065536 SEW11100040HA M1176021-077889 SEW11100041HA M1176021-077889 SEW11100043HA M1176021-077889 SEW11100044HA M1176021-065536 SEW11100045HA M1176021-065536 SEW11100046HA M1176021-077889 SEW11100047HA M1176021-077889 SEW11100048HA M1176021-077889 SEW11100049HA M1176021-052037 SEW11100050HA M1176021-077889 SEW11100051HA M1176021-077889 SEW11100058HA M1176021-073046 SEW11100067HA M1205643-077912 SEW11100068HA M1205643-077912 SEW11100069HA M1205643-077912 SEW11100070HA M1205643-077912 SEW11100071HA M1205643-077912 SEW11100072HA M1205643-077912 SEW11100084HA M1205643-077912 SEW11100087HA M1205643-077912 SEW11100088HA M1205643-077912 SEW11100094HA M1205643-077912 SEW11100096HA M1205643-077912 SEW11100099HA M1205643-088364 SEW11100101HA M1205643-088364 SEW11100103HA M1205643-078388 SEW11100105HA M1205643-078388 SEW11100106HA M1205643-077912 SEW11100107HA M1205643-077912 SEW11100108HA M1205643-077912 SEW11100109HA M1205643-077912 SEW11100110HA M1205643-078388 SEW11100131HA M1205643-078388 SEW11100132HA M1205643-078388 SEW11100133HA M1205643-078388 SEW11100135HA M1205643-093210 SEW11100136HA M1205643-077912 SEW11100137HA…

Recall started

July 7, 2014

Device type

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Root cause (FDA)

Software design

What the company told customers

GE Healthcare "Urgent Medical Device Correction" letter #36102 dated July 7, 2014 to affected customers. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions they can contact Technical Support at 1-800-558-7044 or your local Service Representative.

Recall number

Z-2114-2014

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

Source: FDA · Medical device enforcement report, recall number Z-2114-2014. The agency record governs; check it and the company before acting.