Table Patient Step on RFX/SFX…

Date

June 7, 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

Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems

Reason

Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator.

Distribution pattern

US: Nationwide including DC and Puerto Rico. OUS: Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Egypt, France, Germany, Greece, Honduras, Hungary, Indonesia, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Libya, Malaysia, Malta, Mexico, Panama, Portugal, Russia, Saudi Arabia, Saudi Arabia, Slovakia, Spain, Thailand, United Arab Emirates, United Kingdom, Vietnam.

Quantity

2,380 (2,215 US; 165 OUS)

Codes and lots

FMI 10908 Initial Consignee List Mfg. Lot or Serial # System ID 00000959002WK7 907276RM4 00000966338WK6 256235ORF1 00000966611WK6 256235ORF2 00000956387WK5 205783LRF2 00000525674WK8 205793FR1 00000964963WK3 205387LRF 964349WK5 334732SRF 00000969028WK0 205345RF3 952032WK1 501968LEG 00000510900WK4 501863MLEG 00000277058TU4 479441RF1 00000974520WK9 501321LEG1 29415VP7 928763RF 00000543656WK3 602856LEG 00000551387WK4 602994DRS 984281WK6 928537RM1 00000983374WK0 928537RM2 00000960138WK6 209386ATWRF 00000130329TX6 RADNETRF119 00000546581WK0 650696M6 00000978807WK6 818884LRF1 00000023282M37 RADNETRF1260 00000499668WK2 818331SFX 538693WK3 RADNETRF118 00000972384WK2 RADNETRF144 00000962460WK2 RADNETRF130 00000980889WK0 RADNETRF193 00000530446WK4 209225LEG2 00000531588WK2 209225LEG3 00000517706WK8 510370RFDG1 00000518141WK7 510370RFDG2 00000968783WK1 RADNETRF138 00000963491WK6 RADNETRF137 00000961786WK1 925370LMRF1 00000973156WK3 RADNETRF146 00000953812WK5 RADNETRF126 00000522090WK0 760446RC1 00000969297WK1 909788LF3 00000967126WK4 909788LF4 1025367WK2 RADNETRF129 00000978314WK3 916784LEG 00000978316WK8 619543RF4 00000975431WK8 619543RF5 00000974139WK8 415923LEGACYGI 00000547501WK7 415923PR5 00000963305WK8 408977RF5 00000552931WK8 RADNETRF122 00000966068WK9 RADNETRF139 00001005270WK2 RADNETRF143 00000523402WK6 707462ULEGACY 00000972383WK4 303440BCHRM4 986114WK7 303440LEG1 986513WK0 303355RF 00000503355WK0 970945RM2 00000959073WK8 303CMCRM1 00000954518WK7 719556RM1 00000977456WK3 203331RF1 00000507625WK2 203785RF1 972381WK8 860350RF1 00000543348WK7 703697RF2 00000967162WK9 302392RF 00000961102WK1 302654RF 00000549578WK3 407830RF4 00000956746WK2 561965RM1 00000957833WK7 561965RM3 00000958809WK6 561965RM4 00000538300WK5 305682RM5 546369WK0 305AHLEG2 00000549923WK1 863533RM1 00000963738WK0 941798RM2 00000981461WK7 941798RM3 00000516439WK7 813681RM3 00000519515WK1 813681SPEC1 00000518140WK9 407566CH2 00000979197WK1 239432RF1 00000969627WK9 239931RM2 00000955947WK7 941437RF1 00000966773WK4 561468RM4 00000550144WK0 850862FR3 00000980499WK8 352344RFLEG 00000112375BU1 904755LRAD 00000974170WK3 239369RM3 387184WK5 386362RF1 87793TY6 321752WLG2 00000972386WK7 850626SR4 00000951422WK5 352351RM2 00000970853WK8 352861RF1 00000971022WK9 352861RF2 00000538689WK1 407896RF5 00000529630WK6 407933FL1 00000524475WK1 904672LGY1 00000529192WK7 904672LGY2 00000963293WK6 850747ER1 00000551893WK1 850111RF1 00000506731WK9 904478WF5 00000531358WK0 941629RF2 00000974525WK8 321752WLG1 00000962369WK5 904819RF2 00000534305WK8 904825LEGACY 00000974350WK1 727341RF2 00000969628WK7 727341RF3 00000969619WK6 813634LEG1 00000975429WK2 813634LEG2 00000978458WK8 850325RF1 00000962420WK6 850656RF2 00000969308WK6 954724LEG 00000979786WK1 561798WRM2 34489VP5 403179 37019VP7 403009 402568BU0 403050 532577WK4 403219 Not Available 403258 00000527085WK5 912246MR3 00000530448WK0 912264LEGACY 00000973188WK6 770382LEG2 00000544942WK6 229758LEGACY 00000956847WK8 706576HL1 00000522605WK5 404571DL2 00000970377WK8 404321LEG2 00000966070WK5 706754HR2 00000963310WK8 478994MR1 967884WK8 403294 00000518884WK2 478633DH3 00000516878WK6 478633R1 00000953103WK9 478633R3 00000532968WK5 478633R4 00000963898WK2 912757RF2 00000955368WK6 912765RMD Not Available 1263640 00000541503WK9 912327LD3 000FMITR002796 1334666 Not Available 1186144 00000963795WK0 706554BFL1 00000501270WK3 404867BRF1 00000519905WK4 712336RF 00000972819WK7 208882GX2A 00000552613WK2 815933RF6 00000976869WK8 773356LEG1 00000969285WK6 815284RM2 00000547503WK3 847570RF6 00000973835WK2 847913RF1 00000957800WK6 847657GR4 00000510837WK8 847362CAL 00000497794WK8 708425LD 00000983490WK4 217562PLEG 00000960280WK6 309662JX3 00000968048WK9 618443SRF1 00000978315WK0 864560BJWR1 00000519907WK0 217337CXF1A 00000954100WK4 217337CXF2 00000506734WK3 217383CRF1 00000975577WK8 260425SJRF6 00000003830BC7 713984SB5 00000552619WK9 812482LRF 00000969574WK3 812237TH3 00000970714WK2 785877RF 00000502618WK2 913345MLEG1 544044WK1 913676SR9 00000532969WK3 913317SRM3 00000960804WK3 785543PRF 00000541727WK4 316688RF4 00000972388WK3 620221RF1 00000536174WK6 502875RM2 00000969865WK5 859255RF1 00000972380WK0 606285LEGACY 536550WK7 606256PRE 00000495060WK6 606789XR1 00000962630WK0 606987LEG1 00000955150WK8 606451LEG1 00000951414WK2 318473RD2 00000967364WK1 985748RF 00000982419WK4 985652LEG 00000976993WK6 985882RF1 00000522608WK9 318981MCADVE 00000957655WK4 337981DRS4 00000970749WK8 504885LEG 00000957419WK5 318728RF1 00000543346WK1 318539LEG 00000971903WK0 504391RF1 00000971825WK5 504391RF2 960074WK3 781848RF1 00000538308WK8 781273L2 962275WK4 413748RM5 00000538934WK1 781756W4 00000534769WK5 301981RF5 549581WK7 RADNETRF1241 00000967770WK9 301896RF 529942WK5 RADNETRF1271 00000978808WK4 207255RF2 00000954383WK6 517269RF1 00000953219WK3 517269RF3 00000979585WK7 231547ADV 988710WK0 313593LEG1 00000978805WK0 313593LEG2 00000965500WK2 517353LEGACY 00000957454WK2 517663LEGACY 00000524394WK4 906524ADV1 00000975421WK9 231845RMB 00000975428WK4 FHEOLG1 00000951592WK5 810989RF5 985400WK1 313295LEG 00000951400WK1 507345LEG 00000964575WK5 507332RF 00000969537WK0 507372LEG 00000983757WK6 417235CMRF 00000982589WK4 417269NX4 00000977149WK4 417882CX6 00000533552WK6 417885SXL1 00000978809WK2 417887SNI 00000973834WK5 662627RF4 00000966516WK7 601933LEG 00000551900WK4 228575XR1 00000553331WK0 228575XR2 00000553330WK2 228575XR3 00000977461WK3 601200RM5 00000967778WK2 601364ARF3 00000956274WK5 601364RM2 00000973233WK0 662289RF1 00000982421WK0 318336LEG 00000975683WK4 228809SR2 00000967161WK1 662324RF1 00000973839WK4 601735RF2 00000959586WK9 406538LEG 00000986314WK3 406826RM1 00000552316WK2 919575XR50 00000552933WK4 828452RF1 00000529195WK0 919736SJL1 00000549921WK5 919736SJL2 00000966562WK1 919934JADV1 00000966599WK3 919934JADV2 00000971396WK7 704873DLEG4 00000963221WK7 252641HRLEG 522609WK7 336794MRF1 00000966024WK2 402367RF 00000970543WK5 308282ADV1 00000976667WK6 402887RF 00000977148WK6 402376RF 964350WK3 732840RF1 00000974903WK7 732321LEG6 956777WK7 RADNETRF1266 00000519519WK3 908821LEG 00000972817WK1 201418RF 00000977745WK9 609953LEG1 00000975653WK7 856778RF2 00000969405WK0 732970LEGACY 526628WK0 856582OPRF 00000973623WK2 732505RF 00000979788WK7 505727RM2 00000972167WK1 505722XRM1 00000971607WK7 505722XRM2 00000964482WK4 775738RM2 00000951165WK0 INSIGHTXR014 00000966674WK4 702731SRF13 00000966673WK6 702731SRF7 00000954233WK3 775982ADV1 00000955304WK1 775982XR2 00000973714WK9 775982RF 00000514169WK2 516968LEG1 00000530160WK1 516968LEG2 00000970748WK0 585393VRF2 00000974904WK5 716934RM2 00000965270WK2 914666DRS 00000546244WK5 212463LEGACY 00000963809WK9 516719RFDRS 00000953108WK8 631476RM1 00000552924WK3 516256LEG 544934WK3 914681RM5 00000973841WK0 RADNETRF1256 00000962617WK7 330270LEG 00000971824WK8 740425RF1 00000525668WK0 419483FLUORO 00000530674WK1 330372LEG 00000508469WK4 216971R8 00000977744WK2 740380LEG 00000964962WK5 330837R4 963707WK5 516663LEG 00000548409WK2 740393LEG1 00000961273WK0 740393LEG2 00000544743WK8 419394RF1 00000967340WK1 330332R18 00000539912WK6 4194475 00000550997WK1 580421VRF1 543018WK6 580251DSP 538306WK2 580251ROOM1 00000553329WK4 405359ER3 00000530675WK8 405355RF1 00000525673WK0 918682MRF2 00000552615WK7 405271URF2 00000972818WK9 405372RFT3 00000544940WK0 918567CRF1 00000541893WK4 918294SCRF2 00000541502WK1 918294SCRF3 00000978185WK7 918523LEG1 00000969351WK6 580772RF1 00000547601WK5 717267RF6 959885WK2 717SHCRF1 00000960602WK1 610237LEG1 00000964525WK0 610237OPLEG 00000964264WK6 814375MAB4 00000971674WK7 610278ADV 00000522603WK0 215707LEGACY 00000969026WK4 215748LEG1 00000540269WK8 215898RF1 00000972168WK9 412624F1 00000964802WK3 814827RF 00000978456WK2 610431LEG 000FMITR002678 864261RM15 00000519903WK9 864716RM2 00000530678WK2 803256R1 00000965604WK2 803637RF1 00000535878WK3 843674RF3 00000535876WK7 843674RF4 00000968782WK3 864487UPR2 00000965747WK9 864295GRRM4 00000544739WK6 843293RF 00000532970WK1 605352LEG 00000551896WK4 507537LEG 00000541723WK3 615792RM1 00000531046WK1 423493PRF3 00000539911WK8 615446HRF 00000953009WK8 615264H4 00000978460WK4 731425GI 00000975141WK3 731541RR 00000532515WK4 423837GRF1 00000553952WK3 865475RF 00000959502WK6 423857RF5 00000951884WK6 615769SKYRF3 00000951816WK8 615769SKYRF5 00000951751WK7 615769SKYRF7 00000521502WK5 615781LEG 00000975682WK6 865481RF3 00000548411WK8 931967SRF 512456WK5 817265NAGXR1 00000961772WK1 817472LEG1 00000962910WK6 817472LEG2 00000510617WK4 512476SRM6 00000983500WK0 512448PORF 980878WK3 512454CNTRF 550350WK3 512454RRRRF3 00000528269WK4 956350VRF1 00000952242WK6 409680BVPRF1 00000966029WK1 361857DL1 00000974347WK7 361857ENDO 00000976065WK3 361985RF2 00000535376WK8 512767NWL 00000959001WK9 214947RF4 00000547502WK5 940384DRF1 00000982588WK6 956388RF1 00000536172WK0 915533RF1 00000535370WK1 915592VRF1 00000532293WK8 915592VRF2 00000534304WK1 915595RF4 982066WK3 817336LEGR1 00000955220WK9 817347LEG 00000955387WK6 817551HMLEG4 00000046832TX2 713455LEG 00000965681WK0 713455LEG1 00000965614WK1 713455LEG4 00000983335WK1 713527PRF1 964162WK2 713790SMEND3 00000963015WK3 409539LEG2 00000514172WK6 972751RF 00000980633WK2 281599LEG 00000978455WK4 856346RF 00000992648WK6 936TCIRF1 992178WK4 936TCIRF2 00000951254WK2 956632RM1 00000537113WK3 972548ENDO 00000535879WK1 972548RF2 00000536171WK2 972548RF3 00000956645WK6 214320RF1 00000974462WK4 915520REDDY 00000543349WK5 817255NHLEG 00000975128WK0 915333GOLDER 00000970330WK7 972596GI 00000966006WK9 972596OPLEG1 00000978812WK6 361552LEGD1 00000533548WK4 210575CRF1 00000535369WK3 210575CRF2 00000981459WK1 210614NRF1 00000975150WK4 210614RF1 00000983499WK5 210614SRF1 00000966030WK9 806256RF 00000537108WK3 817424GEXR1 1035192WK2 409822TRF 00000951975WK2 409938ADTX2 00000966774WK2 361788LEGD 00000952466WK1 281338CL5 00000970544WK3 281338LG2 972230WK7 703849RF1 00000543154WK9 276523ADXLEG 00000538303WK9 540236ARF1 00000552929WK2 804541JR2A 00000976668WK4 540862ARF6 00000532517WK0 703478RF 00000970851WK2 804289HDF1 00000971676WK2 804289HDF4 00000978181WK6 804747DHP1 00000976408WK5 804747HDP4 00000970174WK9 540462ARF 00000971104WK5 434447CMRF1 00000963212WK6 509684MC1A 00000980274WK5 509962KRF1 00000974893WK0 253952RM4 00000504041WK5 206228VMA4 00009881460WK9 206386MJLEG 00000958445WK9 206386RF2 00000952137WK8 253756XRM1 00000974523WK3 509486NX2 00000959853WK3 509575PYX4 00000546584WK4 414266RM5 00000543652WK2 414289GI1 00000553948WK1 920303RF1 00000960561WK9 262321RF1 00000979791WK1 715644RF 00000958345WK1 304256RX1A 00000982401WK2 304256RX3A 00000954928WK8 304235WX1B 00000963055WK9 307332RF 00000550998WK9 1855LEGACY 00000969724WK4 0910083012 00000550355WK2 0910082023 00000957389WK0 780624RF 00000989626WK7 905793LEGACY 00000990025WK9 905336LEGACY 00000958696WK7 705544LEGACY 00000989625WK9 905547LEGACY 00000986506WK4 905624LEGACY 00000989627WK5 905845LEGACY 00000989885WK9 416656LEGACY 00000961277WK1 306778RF1 00000961630WK1 EG1112RX07 00000504045WK6 HC0887XR01 00000513395WK4 PMAB01XR03 543015WK2 XR543015WK2 977150WK2 24592065XR 00000534772WK9 0530867LEG 00000961927WK1 56582LEGACY 532967WK7 21971ADVLEG 00000541725WK8 RU1556RX02 00000541891WK8 RU1556RX03 00000957151WK4 10477FLU01 00000978317WK6 00180FLU01 00000957938WK4 00916FLU02 00000966758WK5 00139FLU03 Not Available 90085FLUA3 00000507626WK0 01060FLU02 00000547494WK5 00510FLU03 00000023357M37 907276P500 00001005375WK9 907729RM2P500 00000012142M36 907762P500 00000110928TX9 907729RM1P500 00000010127M39 907543P500 00001005395WK7 907580RM3 00000982307WK1 907580RM4 00001026147WK7 907442KP500 00000022063M32 907443P500 00000003456M31 907747P500 00000017483M39 256235P500 00000998538WK3 251580RF1 00000087393DP5 251580RF2 00001029710WK9 205592PRF1 00000002874M36 205783PRF4 1036065 205971PRF1 1036040WK2 205971PRF2 Not Available AM13DZ2333 00001030301WK4 256737PRF4 00001028159WK0 256486RF1 Not Available 205877BPRF2 00001026858WK9 205877BPRF1 00000994433WK1 256265RF3 00000012639M31 256517RF1 00000012221M38 256517RF3 00000012920M35 256HWCRF3 00000991363WK3 256MIRF1 00000981005WK2…

Recall started

Feb. 6, 2017

Device type

Table, Radiographic, Tilting

Root cause (FDA)

Device Design

What the company told customers

Consignees were sent on 2/6/2017 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# FMI 10908 dated February 3rd, 2017. The letter was addressed to Director of Radiology, Risk Manager/Hospital Administrator & Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact consignee to arrange for the correction.. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recall number

Z-2179-2017

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

Source: FDA · Medical device enforcement report, recall number Z-2179-2017. The agency record governs; check it and the company before acting.