GE Healthcare MRI Systems recall: Software Issue

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number, Serial Number (System ID) : N/A, 000000000R7742 (MP697620); N/A, 00000834BD4B76 (M2865810); 46-294231G1, 0002005-0607-9 (80040MRS02); N/A, 00000293242MR4 (GOLD00EU79); 5127452, 00000274388MR8 (M4160077); 2226300, 000000000R7586 (PL2130MR01); 2226300, 000000000R2785 (A5106403); N/A, N/A (083027060000499); 2226300, 000000000R5870 (A5177224); N/A, 000000000R4933 (C4194430); 2226300, 000000000R7628 (PL1807MR01); 5911000-4 , 00001201FMM0FJ (083027829345912); 2226300, 000000000R5979 (818713MR1); 5308573, 00000292202MR9 (706378MR2); 46-294231G1, 002003-1211-30 (KW1005MR02); 2226300, 000000000R5829 (PL1677MR01); 46-294231G1, 000099-1119-10 (A5401507); N/A, N/A (083027040099711); 46-294231G1, 002001-0530-21 (0920279017); 2377062-61, 00000010633YR6 (808433TMR2); 46-294231G1, 002001-1001-91 (PC1961MR01); 5308573, 00000300778MR8 (0856270046); 2226300, 000000000R5217 (PL1649MR01); N/A, N/A (PL0195MR01); 2226300, 000000000R4456 (70772MRS90); 5127452, 000000HDMR6307 (DK1297MR01); 2226300, 000000000R1970 (M4018076); 46-294231G1, 0000094-1209-4 (178SIGNA15); 2377062-2, 00000963500YM4 (0910272057); 46-294231G1, 002004-0211-05 (PC2703MR02); 46-294231G1, 002001-0301-23 (YM0731); 46-294231G1, 002003-0128-22 (YM2020); 2226300, 000000000R5133 (KAISERVJOMR); 5127452-3, 00001011BD6645 (082427040110); 46-294231G1, 0000098-0617-2 (414SIGNAHOR); 5308573, 00000294505MR3 (34407MRS01); 5107849, 00000275094MR1 (DZ1004MR02); 2226300, 000000000R6384 (0850270266); N/A, 00000000R7803A (2900429); 2214149-2, 00000003388M26 (MRR8311); N/A, 000000000R6449 (110040MR01); 2214149-2, 00000001634M25 (MRR8049); /A, N/A (0910272067); 2226300, 000000000R6691 (A200581902); 2226300, 000000000R6343 (787831SIGNAHDX); 2226300, 000000000R6461 (SA2161MR01); 2226300, 000000000R7934 (78003MRS01); 5308573, 00000291238MR4 (MA1135MR01); 5308573, 00000299348MR3 (07025MRS01); 2226300, 000000000R7004 (PL1426MR02); 2226300, 000000000R7487 (1306777); 2226300, 000000000R6769 (IL1041MR08); 395001, 00000280692MR5 (CC0820MR09); 2226300, 000000000R6889 (PL1735MR01); N/A, 000000000R6609 (M4464817); 2226300, 000000000R6707 (083027207801078); N/A, 00000014680GQ3 (M4033099); 5127452, 000000HDMR3604 (01203MRS01); N/A, N/A (0910274028); 2226300, 000000000R6050 (10563MRS01); 2226300, 000000000R5325 (SA1056MR01); 2226300, 000000000R6042 (SA1047MR01); 46-294231G1, 0002001-0219-8 (281477MWMR); 2226300, 000000000R5823 (A5718006); 2226300, 000000000R6111 (DZ1250MR01); N/A, N/A (DK1228MR07); 46-294231G1, 0000098-1207-9 (IE1028MR02); 2226300, 000000000R5149 (00398MRS01); 2226300, 000000000R5639 (00441MRS01); 2226300, 000000000R7809 (CBSMR1); 2226300, 000000000R5836 (083027862100837); 46-294231G1, 000004-0528-17 (083027602200104); 2226300, 000000000759 (083027603014911); N/A, 002004-0323-16 (GOLD0EU131); 2226300, 000000000R7996 (MRR7977); 2226300, 000000000R7781 (PL1639MR02); N/A, 000000000R7452 (2869229); N/A, N/A (HC2821MR01); 5308573, 00000294659MR8 (083027848131849); 46-294231G1, 0002000-1003-3 (0835270003); 2226300, 000000000R7237 (M4212028); 2395001, 00000276676MR4 (083027842100686); N/A, N/A (0910272088); N/A, N/A (0859270005); 2226300, 000000000R7837 (2913994HDXT); 5127452-3, 00001011BD667C (DZ1005MR01); 2226300, 000000000R7563 (IR1906MR01); 5911000-4 , 00001239FMM01H (083027800039612); 5127452-3, 00000919BD5B8F (FI1024MR02); 2226300, 000000000R7940 (SA2214MR01); 5127452-3, 00000837BD4ESC (0850270435); 46-294231G1, 000006-0523-15 (0850270200); 5127452-3, 00001003BD6435 (083027601000510); 5308573, 00000302567MR3 (083027243783711); 2377062, 00000941265YM1 (600118MR02); N/A, N/A (0850270291); 2395001-3, 00000289020MR0 (083027202100488); 2226300, 000000000R2404 (PL1169MR01); N/A, N/A (083027601013710); N/A, N/A (0910274011); 46-294231G1, 0000099-0506-1 (0910272025); 5127452, 000000HDMR5710 (IE1038MR01); N/A, N/A (083027001018110); N/A, N/A (083027592052828); 2226300, 000000000R4321 (SA1220MR01); 46-294231G1, 002002-1015-30 (PC0114MR04); 46-294231G1, 002003-0820-07 (PL1394MR01); 46-294231G1, 002001-0619-24 (IE1006MR01); 2226300, 0000000000R891 (0920279013); N/A, N/A (0910272038); 46-294231G1, 002000-0418-17 (SA1001MR02); 46-294231G1, 0`2001-0219-13 (259170MR05); N/A, 0000099-1217-4 (10140MRM44); N/A, 00000303865MR0 (10331MRS01); 46-294231G1, 0000096-0614-8 (801224MR); N/A, 0000096-0520-5 (AE1025MR01); 46-294231G1, 002001-0709-20 (0856270038); 5308573, 00000301170MR7 (MRR8186); 5127452, 000000HDMR6250 (00213MRS01); 46-294231G1, 002004-0917-09 (600092MR03); N/A, N/A (0856270050); 46-294231G1, 0000097-0922-9 (213340MR); 46-294231G1, 0000094-0928-7 (4224SIGN15); 5127452, 000000HDMR5751 (70383MRS01); N/A, N/A (083027592002609); 5127452-3, 00000903BD55FD (083027002100119); 2226300, 000000000R7217 (083027848480709); 5127452, 00000HDMR10911 (801262MR2); 46-294231G1, 002001-0425-10 (765INNERMR); 2377062, 00000962578YM1 (519685MR); 2377062-61, 00000009061YR3 (DK1401MR01); 2226300, 000000000R6839 (501268MR); 5308573, 00000301743MR1 (45019MRS01); 5127452, 000000HDMR6310 (0834270012); 2226300, 000000000R6802 (H10649MR06); 5107849-2, 00000288195MR1 (H10652MR08); 2395001, 00000286008MR8 (21234MRM02); 2108800-2, 535651 (SHIMR02604); 2226300, 000000000R6903 (503763MR1); 46-294231G1, 002002-0627-18 (RADNETMR611); N/A, N/A (083027820006912); N/A, N/A (4954MR15T); N/A, 000000000R6911 (2805953); 46-294231G1, 0000091-1022-5 (205431MR2); 5911000-4 ,00001227FMM06G (083027200018712); N/A, N/A (083027590475005); N/A, N/A (1111395); 2214149-2, 00000005560M28 (IQ1394MR01); N/A, N/A (RADNETMRM01); 46-294231G1, 002005-0627-18 (ALLIANCESIG421); 46-294231G1, 0000099-0125-9 (907276ARMR); N/A, N/A (6444MRDICO); N/A, N/A (2809956); 46-294231G1, 0000001-0215-1 (INSIGHTMR1915); 2226300, 000000000R6838 (623445MR1); 2377062-2, 00000943572YM8 (201632MR); 46-294231G1, 0002002-0510-7 (ALLIANCESIG474); 46-294231G1, 002002-0125-22 (559585CCICMR2); 46-294231G1, 002002-0405-12 (205783TSMR); 5127452, 000000HDMR5415 (850484OMRI); 5308573, 00000300970MR1 (RADNETMR507); 5127452, 00000HDMR10886 (916423MR); 5127452, 000000HDMR3674 (501370CHMR); 5107849, 00000269580MR7 (PL3040MR01); 46-294231G1, 002004-1209-10 (YM1260); 2395001-2, 00000284023MR9 (083027002101567); 46-294231G1, 0000007-403-15 (083027802000517); 5127452, 000000HDMR5483 (1063THDX); 5127452, 000000HDMR3964 (SA1001MR03); 2395001-2, 00000280672MR7 (00440MRS02); N/A, 000000HDMR5233 (110037MR02); 5127452-3, 00001012BD66E0 (083027000143110); 2358431, 00000000WB0607 (AZ4013MR01); 5127452-3, 00001009BD6557 (BA4080MR01); 5308573-2, 00000299495MR2 (MRWB0540); N/A, N/A (5606MRS3T); 5127452-3, 00001009BD65F2 (083027009445910); N/A, N/A (773665MR3T); 5127452-3, 00001009BD6579 (2887688HDXT30T); 5127452, 00000275305MR1 (831423MR); N/A, N/A (2558948); 46-294231G1, 0002005-0607-4 (7067213TMR); 5127452-3, 000S0933BD5DFD (719542MR); N/A, 002003-0912-12 (DK1047MR04); 5127452, 000000HDMR5406 (0910273033); 5127452, 000000HDMR2642 (0850270218); 5421824-2, 00000310388MR4 (083027240009214); 2377062-2, 00000963651YM5 (IL1194MR01); 46-294231G1, 002005-1020-29 (HBLUCOMR01); N/A, 002004-0917-02 (00473MRS01); N/A, N/A (MR4013522); N/A, N/A (2679752); N/A, N/A (2541440); 2226300, 000000000R1733 (MRR1733); 2226300, 0000000000R273 (MRR273); 46-294231G1, 000099-0205-11 (0910272023); N/A, N/A (PL1681MR01); N/A, N/A (H4443MR04); 5308573, 00000301741MR5 (MRR8267); 5308573, 00000301223MR4 (2918179MR); 2214149-2, 00000002339M20 (MRR8325); 2214149-2, 00000003155M29 (MRR8701); N/A, 000096-0126-27 (A020MR02); N/A, 00000175300MR3 (10079MRM42); N/A, N/A (5272MRSIGNA4X); 2226300, 000000000R5436 (DEN00700); 2226300, 000000000R6601 (CE165329); N/A, N/A (0910273026); 46-294231G1, 002002-1126-23 (082427100148); 5308573, 00000300700MR2 (DEN00933); 46-294231G1, 000099-0122-13 (YE600210); 5127452, 000000HDMR5250 (DZ1009MR02); 2226300, 000000000R3823 (CS1275MR02); 2226300, 000000000R2680 (ZA2159MR02); 2214149-2, 00000014057GQ4 (082427030054); 2226300, 000000000R5680 (082427130073); 46-294231G1, 002005-1201-30 (HU1039MR03); 2226300, 000000000R6212 (DK1306MR02); 2214149-2 ,00000007668M27 (082427280013); 5308573, 00000301498MR2 (082427240016); 2226300, 000000000R7667 (082427050024); 5308573, 00000301500MR5 (MRR8257); 2226300, 000000000R6024 (CS1020MR01); 5308573, 00000291246MR7 (2761886); N/A, 000000000R6222 (2726027); 5308573, 00000301383MR6 (082427030063); 2226300, 000000000R7426 (082427100239); 46-294231G1, 002001-0718-35 (0910273020); 5308573, 00000301264MR8 (082427030061); 2226300, 000000000R6289 (082427160057); 2226300, 000000000R6200 (MPX19700); 2226300, 000000000R7028 (082427210051); 2226300, 000000000R6582 (DZ1259MR01); 2226300, 000000000R5895 (SA1129MR02); 2226300, 000000000R6955 (2807539); 2226300, 000000000R5724 (PPS18202); 2226300, 000000000R5733 (RU1550MR01); 2226300, 000000000R6139 (BG4538MR01); 2226300, 000000000R6439 (RU1279MR01); 2226300, 000000000R5352 (GE1004MR01); N/A, 000000000R6511 (2767032); 2214149-2, 00000004486M27 (082427080033); 2226300, 000000000R6806 (082427040088); 2226300, 000000000R5120 (0910273030); 2226300, 000000000R7718 (082427250022); 2226300, 000000000R5579 (RU1067MR02); N/A, N/A (082427040098); 5421824-2, 00000310944MR4 (082427080047); 2226300, 000000000R7870 (MRR7870); 46-294231G1, 000099-0817-11 (MPX47002); 5308573, 00000298557MR0 (0853270042IB1); 5421824, 00000311257MR0 (082427190081); 2214149-2, 00000002805M20 (082427040129); 2226300, 000000000R7050 (UPW00400); 2226300, 000000000R7884 (NPV85600); 2214149-2, 00000002750M28 (CS1338MR01); 2226300, 000000000R7342 (082427030049); 2214149-2, 00000003393M26 (RU1031MR01); 2226300, 000000000R7130 (CS1319MR01); 5127452-3, 00001012BD66A2 (0853270074IB1); 46-294231G1, 0002005-1201-2 (082427120126); N/A, N/A (082427160098); 46-294231G1, 0000099-0414-7 (CP223906); N/A, 000000000R3618 (BG4641MR01); 46-294231G1, 002002-1030-14 (H3943MR01); 46-294231G1, 002001-1018-36 (ZA2103MR01); 2214149-2, 00000005509M25 (082427230084); 5421824, 00000311572MR2 (082427140132); 5269997-9, 00000015025YR0 (0828270033); 2226300, 000000000R5260 (082427030103); 46-294231G1, 0000095-1120-5 (RU1089MR01); 5421824, 00000311574MR8 (082427230107); 2377062-61, 00000011084YR1 (27008MRS01); 2214149-2, 00000003870M23 (RU1457MR01); 5127452-3 ,00000838BD4ECB (35062MRS02); 7849-2, 00000283036MR2 (55027MRS01); 2395001, 00000285169MR9 (JO4109MR01); 5421824-2, 00000311280MR2 (082427230097); 507849-2, 00000288588MR7 (DK1393MR01); 2214149-2 , 00000007860M20 (082427210142MM3); 2214149-2, 00000004304M22 (H2294MR07); 2226300, 000000000R7091 (48021MRS01); 2214149-2, 00000004492M25 (KA2839MR01); 2214149-2, 00000003509M27 (RU1173MR01); 2226300, 000000000R3065 (082427160161); N/A, N/A (570844HCM3T); 5127452, 000000HDMR3447 (DPM32124); 5421834-2, 00000311145MR7 (082427130084); 5127452-3, 00000919BD5BB7 (082427220041); N/A, N/A (082427120070); 5127452, 000000HDMR1125 (082427040073); 2395001-2, 00000275466MR1 (DEN51500); 5127452, 000000HDMR5758 (082427040092); N/A, 0000000HDMR357 (CS1006MR03); 5127452, 000000HDMR1900 (0910274020); 5127452-3, 00001003BD640C (082427080026); 5127452-3, 00000938BD5F17 (082427190069); 5127452, 00000275290MR5 (DPC79014); N/A, N/A (082427100192); 5308573-2, 00000299275MR8 (082427200036); 5127452-3, 00001012BD66E1 (PER08626); 5127452-3, 00001003BD640D (PER28007); 5127452-3, 00000938BD5F14 (RO1189MR01); 5127452, 000000HDMR6035 (082427140120); 5107849-3, 00000302786MR9 (MRJ061); N/A, 00000293706MR8 (NPV58000); N/A, N/A (0910276003); N/A, N/A (626570MR); N/A, N/A (907561AIMR); N/A, N/A (309451MR); 46-294231G1, 000002-1003-15 (201967MR); 2226300, 000000000R5771 (0853270133GS); 46-294231G1, 0000099-0521-6 (ALLIANCESIG85); 2377062-61, 00000011265YR6 (MRR6469); N/A, N/A (083027067005818); N/A, N/A (520GVHMR); N/A, N/A (2939576HDXT); N/A, N/A (520872MR); 2226300, 000000000R1970 (H10650MR08); 2226300, 000000000R6733 (A197998701); 2226300, 000000000R6448 (0828270030); 2214149-2 , 00000015124GQ1 (0834270011); N/A, 002000-0907-10 (CPM80615); 5127452, 000000HDMR5960 (0834270010); 5127452-3 , 00001009BD6578 (0834270015); 46-294231G1, 000096-0126-15 (YP630007); 2226300, 000000000R6352 (YP600200); 2226300, 000000000R2306 (RU1086MR01); 46-294231G1, 0002002-0506-3 (FEC80061); 2377062, 4337424 (MEX34410); 5127452, 000000HDMR4309 (UPW28900); 2395001, 00000280327MR8 (UPW21605); 2226300, 000000000R5291 (YP601000); 46-294231G1, 002000-0426-18 (0856270029); 46-294231G1, 0000099-0722-1 (ME208331); 2226300, 000000000R4276 (FPF35809); 46-294231G1, 002004-1117-12 (0828270020IB01); N/A, 00000001400M21 (NPV84508); 2377062-61 , 00000011251YR6 (MEX71105); 2395001, 00000283516MR3 (MP118825); 46-294231G1, 002003-1027-20 (A5103135); 5396469-2, 00000310306MR6 (NO1005MR02); 46-294231G1, 0000095-0810-3 (A5278401); 46-294231G1, 002003-0903-12 (A5111732); 2226300, 000000000R4164 (A5684809); 2226300, 000000000R6773 (PER08305); 2226300, 000000000R6502 (2766544); 2226300, 000000000R5403 (H1063MR18); 2226300, 000000000R5912 (H1420MR14); 46-294231G1, 002002-0809-08 (CPZ09609); 46-294231G1, 002003-0708-01 (PER00417); 46-294231G1, 002000-1013-15 (A5632405); 2214149-2, 00000002229M23 (MRR8295); 2226300, 000000000R2375 (A5745509); N/A, N/A (0853270100); N/A, N/A (083027100973317); N/A, 002002-0814-05 (H1066MR16); 46-294231G1, 000093-0528-15 (DE528434); 2226300, 000000000R7136 (0910272086); 2395001, 00000280778MR2 (0843270015); N/A, N/A (0910274013); 46-294231G1, 0000098-0608-5 (0910272020); 2395001, 00002835171MR1 (083027040006015); 2226300, 000000000R6574 (2767673); 2226300, 000000000R5159 (3882647967MROCC); 46-294231G1, 0002005-0331-3 (H12041MR02); 46-294231G1, 0000000MRU0407 (IE1025MR01); 2226300, 000000000R3756 (PVIL01MR01); 46-294231G1, 000097-1107-10 (PNUE01MR03); 46-294231G1, 002005-0823-17 (HPAD01MR01); N/A, N/A (PL1774MR02); 2226300, 000000000R6092 (0859270002); 2226300, 000000000R6021 (0859270001); 5127452, 000000HDMR1019 (RU3023MR01); N/A, 000000HDMR5374 (PM1633MR03); 2226300, 000000000R4692 (PL1704MR01); N/A, N/A (083027242000437); 2226300, 000000000R1663 (PC0976MR01); 46-294231G1, 0002001-0323-1 (MA1152MR01); 46-294231G1, 0000095-0912-5 (PX2261MR02); 5127452, 1529759 (MC6946MR07); 2395001-2, 00000278549MR1 (RU1127MR02); 46-294231G1, 000006-0523-10 (RU1834MR01); 5127452, 3877 (00240MRS01); 46-294231G1, 002000-0816-10 (PC0396MR03); 46-294231G1, 0000098-0528-5 (A5566913); 5127452, 000000HDMR2483 (A171995610); 2226300, 000000000R2753 (DK1343MR01); 2226300, 000000000R6499 (A5192410); N/A, 000000000R7233 (1324655); 5308573, 00000302145MR8 (MRR8303); 2226300, 000000000R6460 (22MRHDX2762068); 2226300, 000000000R5214 (H17641MR12); N/A, 02001-12210-13 (A042MR01); 2226300, 000000000R7197 (2835341HDX); 2395001-2, 00000286650MR7 (H2193MR05); 2226300, 000000000R6520 (A51273121); 2226300, 000000000R2396 (MRR2396); 46-294231G1, 000007-0530-16 (UK28); 46-294231G1, 000097-0331-10 (DK1029MR01); 2214149-2 , 00000009304M27 (MRR8592); 2320288, 00000096546WH7 (10695MRM01); 2226300, 000000000R2753 (DK1394MR01); 2357500, 00000249262MR7 (16683THDX); 2226300, 000000000R7564 (A5146405); N/A, N/A (650742KSSFMR); 46-294231G1, 0000096-0419-4 (0920279006); N/A, N/A (916SRFMR); N/A, N/A (7366); 46-294231G1, 002002-0517-19 (IR1026MR01); N/A, N/A (0847270018); 46-294231G1, 0000099-0329-4 (A5127353); N/A, N/A (0847270025); 46-294231G1, 002001-1018-32 (PC7425MR01); N/A, 000000000R1116 (AH4511MR02); N/A, N/A (843549MR); 2226300, 000000000R1533 (LLS0120); 5308573, 00000293870MR2 (CC0820MR10); 46-294231G1, 002004-0713-22 (393115MR01); N/A, N/A (00200MRS03); N/A, N/A (ALLIANCESIG270); N/A, 0002000-1102-1 (DK1042MR01); 46-294231G1, 002004-0206-15 (397480MR01); N/A, N/A (707571KSRMR); N/A, N/A (8183MRLX); 2377062-2, 00000951076YM9 (805687MR2); 2226300, 0000000000R575 (HC1770MR01 ); N/A, N/A (A5183710); N/A, N/A (585786MRI); 2226300, 000000000R6712 (0847270023); 2226300, 000000000R5610 (0843270017); 46-294231G1, 002002-0315-13 0847270001); 46-294231G1, 0002000-0301-4 (SA1012MR01); N/A, N/A (570844TWINSPEED); N/A, N/A (422SIGNA15); N/A, 002000-1221-14 (DK1047MR03); 46-294231G1, 002003-0929-03 (N4192928); N/A, N/A (0910274008); 46-294231G1, 002003-0818-13 (34026MRS03); N/A, 00000275019MR8 (35045MRS03); 2226300, 000000000R5050 (082427130074); N/A, 00000310642MR4 (082427130082); 5421824, 00000311573MR0 (082427180036); 5453862-2, 308735MR0 (082427240048); N/A, N/A (PL3331MR01); N/A, N/A (409637LX1); N/A, N/A (618798SMR).

Product

GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX…

Recalling firm

GE Medical Systems, LLC

Quantity

5,200 total units

Distribution

Worldwide Distribution: US (nationwide) including states of:: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and countries of: Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, CYPRUS, Czech Republic, DENMARK, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Iceland, India, Indonesia, Iran, IRAQ, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Portugal, Puerto Rico, Russia, Saudi Arabia, SINGAPORE, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, and Vietnam.

Recall date

October 24, 2018

Classification

Class II

Status

Terminated

Agency

FDA (device)