GE Healthcare…

Date

May 28, 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, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.

Reason

When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmission (NMT) values may indicate a deeper level of muscle relaxation than the actual level of muscle relaxation. In the clinical situation visual movements of the hand are seen after TOF (Train of Four) stimulation, but the patient monitor shows no counts, or counts are not corresponding to the actual a

Distribution pattern

US Nationwide Distribution in the states of: AR, CA, CO,DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MI, MN, MO, NC, NV, NY, OH, OK, TN, TX, UT, WA, WI, WY. OUS: ARGENTINA. AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGRY, INDIA, IRA, ISRAEL, ITALY, JAPAN, KAZAKTSTAN, KUWAIT, LATVIA, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PANAMA, POLAND, QATAR, ROMANIA, RUSSIAN, F¿D¿RATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, TAIWAN, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA.

Quantity

1,794 (471 units US, 1,323 units OUS)

Codes and lots

Mfg Lot or Serial # SJC13057999HA SJC13058001HA SJC13058005HA SJC13058006HA SJC13058007HA SJC13058008HA SJC13058009HA SJC13058010HA SJC13058011HA SJC13058012HA SJC13058013HA SJC13058014HA SJC13058015HA SJC13058017HA SJC13058018HA SJC13058020HA SJC13058022HA SJC13058024HA SJC13058025HA SJC13058028HA SJC13172551HA SJC13172553HA SJC13172554HA SJC13172555HA SJC13172556HA SJC13172558HA SJC13172559HA SJC13172562HA SJC13172564HA SJC13172565HA SJC13172568HA SJC13172620HA SJC13172630HA SJC13172766HA SJC13172767HA SJC13172769HA SJC13172770HA SJC13172772HA SJC13172774HA SJC13172775HA SJC13172776HA SJC13193229HA SJC13193233HA SJC13193234HA SJC13203267HA SJC13203268HA SJC13203269HA SJC13234522HA SJC13234523HA SJC13234524HA SJC13234528HA SJC13234529HA SJC13234530HA SJC13234531HA SJC13234532HA SJC13234533HA SJC13234534HA SJC13234535HA SJC13234538HA SJC13234540HA SJC13234541HA SJC13234542HA SJC13234543HA SJC13244575HA SJC13244581HA SJC13244583HA SJC13244584HA SJC13244588HA SJC13244589HA SJC13244590HA SJC13244592HA SJC13244593HA SJC13244594HA SJC13244665HA SJC13244666HA SJC13244668HA SJC13244669HA SJC13244670HA SJC13244672HA SJC13244674HA SJC13244675HA SJC13244677HA SJC13244678HA SJC13244679HA SJC13244680HA SJC13244681HA SJC13244682HA SJC13244929HA SJC13244930HA SJC13244931HA SJC13244932HA SJC13244938HA SJC13245120HA SJC13245121HA SJC13245122HA SJC13245123HA SJC13245124HA SJC13255139HA SJC13255140HA SJC13255141HA SJC13255142HA SJC13255143HA SJC13255144HA SJC13255145HA SJC13255146HA SJC13255147HA SJC13255148HA SJC13255320HA SJC13255322HA SJC13255324HA SJC13255328HA SJC13255329HA SJC13255350HA SJC13255351HA SJC13255353HA SJC13255355HA SJC13255358HA SJC13255359HA SJC13265506HA SJC13265508HA SJC13265509HA SJC13265555HA SJC13265556HA SJC13265557HA SJC13265558HA SJC13265562HA SJC13265570HA SJC13265571HA SJC13265572HA SJC13265573HA SJC13265574HA SJC13265575HA SJC13265576HA SJC13265577HA SJC13265578HA SJC13265580HA SJC13265582HA SJC13275790HA SJC13275791HA SJC13275792HA SJC13275793HA SJC13275794HA SJC13275795HA SJC13275796HA SJC13275797HA SJC13275804HA SJC13275805HA SJC13276097HA SJC13276098HA SJC13276099HA SJC13276101HA SJC13276102HA SJC13276104HA SJC13276106HA SJC13276109HA SJC13276110HA SJC13276111HA SJC13276112HA SJC13276113HA SJC13286329HA SJC13286333HA SJC13286334HA SJC13286335HA SJC13286340HA SJC13286341HA SJC13286401HA SJC13286407HA SJC13286410HA SJC13286609HA SJC13286615HA SJC13286616HA SJC13296973HA SJC13296974HA SJC13296978HA SJC13327704HA SJC13327705HA SJC13327706HA SJC13327710HA SJC13327711HA SJC13327712HA SJC13327941HA SJC13327942HA SJC13327943HA SJC13327944HA SJC13327945HA SJC13327946HA SJC13327947HA SJC13327948HA SJC13327949HA SJC13327950HA SJC13327951HA SJC13327952HA SJC13327953HA SJC13327954HA SJC13327955HA SJC13327956HA SJC13327957HA SJC13327958HA SJC13327959HA SJC13327960HA SJC13338115HA SJC13338116HA SJC13338117HA SJC13338118HA SJC13338119HA SJC13338120HA SJC13338121HA SJC13338122HA SJC13338123HA SJC13338124HA SJC13338125HA SJC13338126HA SJC13338127HA SJC13338128HA SJC13338129HA SJC13338130HA SJC13338131HA SJC13338132HA SJC13338133HA SJC13338137HA SJC13338138HA SJC13338139HA SJC13338140HA SJC13338141HA SJC13338142HA SJC13338143HA SJC13338144HA SJC13338145HA SJC13338146HA SJC13338148HA SJC13338149HA SJC13338150HA SJC13338151HA SJC13338152HA SJC13338154HA SJC13338155HA SJC13338156HA SJC13338158HA SJC13338159HA SJC13369172HA SJC13369180HA SJC13369288HA SJC13369289HA SJC13369302HA SJC13369304HA SJC13369305HA SJC13369308HA SJC13369309HA SJC13369311HA SJC13369312HA SJC13379525HA SJC13379526HA SJC13379527HA SJC13379528HA SJC13380324HA SJC13380335HA SJC13380336HA SJC13380340HA SJC13390823HA SJC13390824HA SJC13390825HA SJC13390826HA SJC13390827HA SJC13390828HA SJC13390829HA SJC13390830HA SJC13390831HA SJC13390832HA SJC13390833HA SJC13390834HA SJC13390835HA SJC13390836HA SJC13390837HA SJC13390838HA SJC13390839HA SJC13390840HA SJC13390841HA SJC13390842HA SJC13401196HA SJC13401197HA SJC13401198HA SJC13401199HA SJC13401200HA SJC13401202HA SJC13401330HA SJC13401332HA SJC13401335HA SJC13401356HA SJC13422120HA SJC13422125HA SJC13422127HA SJC13422130HA SJC13422131HA SJC13422132HA SJC13422133HA SJC13422135HA SJC13422136HA SJC13443320HA SJC13443330HA SJC13443581HA SJC13453996HA SJC13453997HA SJC13453998HA SJC13453999HA SJC13454000HA SJC13454001HA SJC13454002HA SJC13454003HA SJC13454004HA SJC13454005HA SJC13454006HA SJC13454008HA SJC13476331HA SJC13476390HA SJC13476391HA SJC13476392HA SJC13476393HA SJC13476396HA SJC13476397HA SJC13476398HA SJC13486747HA SJC13486748HA SJC13487117HA SJC13487118HA SJC13487119HA SJC13487120HA SJC13487121HA SJC13487122HA SJC13487125HA SJC13487126HA SJC13487127HA SJC13487128HA SJC13497710HA SJC13508540HA SJC13508543HA SJC13508545HA SJC13508546HA SJC13508547HA SJC13508548HA SJC13508549HA SJC13508550HA SJC13508551HA SJC13508552HA SJC13508553HA SJC13508554HA SJC13508555HA SJC13508556HA SJC13508557HA SJC13508686HA SJC13508687HA SJC13508689HA SJC13508690HA SJC13508691HA SJC13508692HA SJC13508693HA SJC13508694HA SJC13508695HA SJC13508696HA SJC13508697HA SJC13508698HA SJC13508699HA SJC13508700HA SJC13508701HA SJC13508702HA SJC13508703HA SJC13508704HA SJC13508821HA SJC13508822HA SJC13508823HA SJC13508824HA SJC13508825HA SJC13508826HA SJC13508827HA SJC13508828HA SJC13508829HA SJC13508838HA SJC13508855HA SJC13508860HA SJC13508871HA SJC13508884HA SJC13508890HA SJC13518937HA SJC13518938HA SJC13518942HA SJC13518949HA SJC13518950HA SJC13518952HA SJC13518953HA SJC13519179HA SJC13519180HA SJC13519181HA SJC13519182HA SJC13519183HA SJC13529499HA SJC14019738HA SJC14019739HA SJC14019740HA SJC14019741HA SJC14019742HA SJC14019743HA SJC14019744HA SJC14019745HA SJC14019747HA SJC14019748HA SJC14019749HA SJC14019750HA SJC14019751HA SJC14019752HA SJC14019753HA SJC14019754HA SJC14019755HA SJC14019756HA SJC14019757HA SJC14019758HA SJC14019759HA SJC14019760HA SJC14019761HA SJC14019762HA SJC14019763HA SJC14019764HA SJC14019765HA SJC14019766HA SJC14019767HA SJC14020207HA SJC14020208HA SJC14020209HA SJC14020210HA SJC14020211HA SJC14020212HA SJC14020213HA SJC14020214HA SJC14020215HA SJC14020219HA SJC14020220HA SJC14020222HA SJC14020227HA SJC14020232HA SJC14020234HA SJC14030671HA SJC14030672HA SJC14030673HA SJC14030677HA SJC14030678HA SJC14030679HA SJC14030680HA SJC14030682HA SJC14030683HA SJC14030684HA SJC14030685HA SJC14030763HA SJC14030766HA SJC14030767HA SJC14030768HA SJC14030769HA SJC14030771HA SJC14030772HA SJC14030773HA SJC14030774HA SJC14030780HA SJC14030781HA SJC14030782HA SJC14041563HA SJC14041565HA SJC14041789HA SJC14041804HA SJC14041806HA SJC14041809HA SJC14041810HA SJC14041811HA SJC14041812HA SJC14041813HA SJC13172552HA SJC13172567HA SJC13172601HA SJC13172765HA SJC13172768HA SJC13265751HA SJC13286400HA SJC13338369HA SJC13348830HA SJC13379521HA SJC13379523HA SJC13379524HA SJC13379530HA SJC13379531HA SJC13379532HA SJC13379535HA SJC13497673HA SJC13497679HA SJC13213581HA SJC13380222HA SJC13476343HA SJC13476347HA SJC13497695HA SJC13275803HA SJC13286409HA SJC13286411HA SJC13286612HA SJC13487260HA SJC13487262HA SJC13487263HA SJC13487264HA SJC13487266HA SJC13487267HA SJC13338463HA SJC13401370HA SJC13172607HA SJC13172611HA SJC13172617HA SJC13172627HA SJC13172759HA SJC13193222HA SJC13203253HA SJC13203264HA SJC13203275HA SJC13265708HA SJC13275799HA SJC13275800HA SJC13275806HA SJC13296971HA SJC13380001HA SJC13380002HA SJC13380010HA SJC13401201HA SJC13401203HA SJC13401204HA SJC13401205HA SJC13401206HA SJC13401208HA SJC13401209HA SJC13401210HA SJC13401211HA SJC13401212HA SJC13401213HA SJC13401216HA SJC13401217HA SJC13401218HA SJC13401219HA SJC13401220HA SJC13401221HA SJC13401222HA SJC13401223HA SJC13401224HA SJC13401317HA SJC13401319HA SJC13401324HA SJC13464868HA SJC13464877HA SJC13464881HA SJC13487140HA SJC13487274HA SJC13487275HA SJC13487276HA SJC13487279HA SJC13497669HA SJC13497670HA SJC13497671HA SJC13497680HA SJC13497681HA SJC13497683HA SJC13497685HA SJC13172625HA SJC13172757HA SJC13172758HA SJC13172761HA SJC13213499HA SJC13213500HA SJC13244585HA SJC13296983HA SJC13380227HA SJC13380228HA SJC13380230HA SJC13380323HA SJC13380326HA SJC13380330HA SJC13380339HA SJC13380342HA SJC13464876HA SJC13476328HA SJC13476388HA SJC13476389HA SJC13508879HA SJC13508880HA SJC13519273HA SJC13519276HA SJC13519277HA SJC13519390HA SJC13519395HA SJC14020231HA SJC14030681HA SJC14030761HA SJC14030762HA SJC14030776HA SJC14030783HA SJC14030784HA SJC14030821HA SJC14030822HA 8225152 8249709 8294161 8311854 8311856 8311857 SJC13213517HA SJC13223969HA SJC13327707HA SJC13327708HA SJC13327713HA SJC13369310HA SJC13379976HA SJC13380011HA SJC13380023HA SJC13380220HA SJC13380223HA SJC13380224HA SJC13380225HA SJC13380226HA SJC13380229HA SJC13476373HA SJC13487143HA SJC13497677HA SJC13497678HA SJC13497701HA SJC13497732HA SJC13508852HA SJC13508854HA SJC13508857HA SJC13508859HA SJC13508872HA SJC13508873HA SJC13508875HA SJC13508877HA SJC13508883HA SJC13529498HA SJC14020229HA SJC14031146HA SJC13476368HA SJC13476369HA SJC13476370HA SJC14041790HA SJC14041791HA SJC14041792HA SJC14041793HA SJC14041794HA SJC14041795HA SJC14041796HA SJC14041797HA SJC14041798HA SJC14041799HA SJC14041800HA SJC14041801HA SJC14041802HA SJC14041803HA SJC14041817HA SJC14041822HA SJC14041824HA SJC14041825HA SJC14041826HA SJC14041827HA SJC14042243HA SJC14042244HA SJC14042245HA SJC13172557HA SJC13172569HA SJC13172570HA SJC13172604HA SJC13213571HA SJC13276095HA SJC13454019HA SJC13487138HA SJC13487144HA SJC14030819HA SJC14030830HA SJC14041818HA SJC14041819HA SJC14041820HA SJC13193231HA SJC13213506HA SJC13348832HA SJC13369139HA SJC13369140HA SJC13369157HA SJC13369161HA SJC13369169HA SJC13369173HA SJC13369295HA SJC13369297HA SJC13369299HA SJC13422139HA SJC13422207HA SJC13433030HA SJC13433031HA SJC13433037HA SJC13433038HA SJC13433039HA SJC13433040HA SJC13433041HA SJC13433042HA SJC13433043HA SJC13433044HA SJC13433045HA SJC13433047HA SJC13433051HA SJC13433052HA SJC13433053HA SJC13433054HA SJC13433055HA SJC13433056HA SJC13433057HA SJC13433058HA SJC13433059HA SJC13433071HA SJC13433075HA SJC13433076HA SJC13433078HA SJC13433079HA SJC13433092HA SJC13443325HA SJC13476344HA SJC13476375HA SJC13476399HA SJC13476400HA SJC13476401HA SJC13476402HA SJC13476403HA SJC13476404HA SJC13487154HA SJC13497687HA SJC13497704HA SJC13497708HA SJC13497709HA SJC13497711HA SJC13497728HA SJC13497729HA SJC13497739HA SJC13497740HA SJC13508466HA SJC13508467HA SJC13508472HA SJC13508473HA SJC13508474HA SJC13508475HA SJC13508477HA SJC13508480HA SJC13508481HA SJC13508538HA SJC13508542HA SJC13508688HA SJC13508881HA SJC13508882HA SJC13508885HA SJC13508888HA SJC13508889HA SJC13518934HA SJC13518935HA SJC13518936HA SJC13518947HA 8249700 8249739 8277062 8277149 8283742 8283775 8286326 SJC13213580HA SJC13203250HA SJC13203260HA SJC13203261HA SJC13203248HA SJC13203249HA SJC13379529HA SJC13379534HA SJC13379540HA SJC13379603HA SJC13379604HA SJC13380003HA SJC13380004HA SJC13380006HA SJC13380007HA SJC13380008HA SJC13380009HA SJC13380012HA SJC13380013HA SJC13380014HA SJC13380015HA SJC13380016HA SJC13380017HA SJC13380018HA SJC13380019HA SJC13380020HA SJC13380021HA SJC13380022HA SJC13380024HA SJC13380026HA SJC13380027HA SJC13487277HA SJC13487278HA SJC13497668HA SJC13497682HA SJC13497693HA SJC13497696HA SJC13497697HA SJC13497700HA SJC13497703HA SJC13497705HA SJC13497706HA SJC13497707HA SJC13497730HA SJC13497731HA SJC13508830HA SJC13508831HA SJC13508832HA SJC13508834HA SJC13508836HA SJC13508837HA SJC13508839HA SJC13508840HA SJC13508843HA SJC13508844HA SJC13497690HA SJC13497691HA SJC13497741HA SJC13497742HA SJC13497743HA SJC13508464HA SJC13508465HA SJC13508468HA SJC13508469HA SJC13487273HA SJC13172773HA SJC13422123HA SJC14030754HA SJC14030756HA SJC14030760HA SJC14030764HA SJC13058016HA SJC13172563HA SJC13172771HA SJC13213579HA SJC13213582HA SJC13223962HA SJC13234214HA SJC13234537HA SJC13244582HA SJC13244587HA SJC13244591HA SJC13244667HA SJC13244671HA SJC13244683HA SJC13255323HA SJC13255325HA SJC13255352HA SJC13255356HA SJC13255357HA SJC13265507HA SJC13265552HA SJC13265553HA SJC13265559HA SJC13265560HA SJC13265561HA SJC13265579HA…

Recall started

April 9, 2014

Device type

Stimulator, Nerve, Peripheral, Electric

Root cause (FDA)

Software design

What the company told customers

GE Healthcare sent an "Urgent Medical Device Correction" letter (Ref 36099) dated April 9, 2014 to affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information (contact Technical Support at 1-800-558-7044 or your local Service Representative). UPDATE: On May 11, 2015 a second GE Healthcare letter FMI 36099-2 was sent to OUS consignees. The updated report was for additional affected modules due to FRU installation.

Recall number

Z-1640-2014

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

Source: FDA · Medical device enforcement report, recall number Z-1640-2014. The agency record governs; check it and the company before acting.