FDAFDA · Food and drugs·Recall number Z-2131-2016
GE Healthcare, Discovery MR750w
Published July 13, 2016 · Recall initiated: June 8, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. No injury has been reported to GE as a result of this issue.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- US: AK, AZ, CA, COM, CT , DC, FL, GA, GU, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH,OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY. OUS: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bermuda Brazil Bulgaria Canada China Egypt France Germany Hungary India Indonesia Ireland Italy Japan Kazakhstan Korea (Republic of) Kuwait Lebanon Mexico Netherlands New Zealand Poland Qatar Romania Russia Russian Federation Saudi Arabia Singapore Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom Uruguay
- Lot
- Mfg Lot or Serial # System ID 00001250FMM03D 9075653T 00001308FMM00B 602863MR Missing_SN_GON4205067 480342MR3 00001134FMM10E 928348MR 00001140FMM0FX RADNETMR597 N/A 530CHI750W N/A 858824MR1 00000000UA0083 408356MR1 00001204FMM058 RADNETMR599 00000000UA0262 949760MR3 00000308185MR8 510449MR750W 00000000UA0075 619543HDMR4 00000000UA0118 858622HDMR1 00001204FMM052 415CB3TW 00001309FMM08B RADNETMR613 00001307FMM09Y 415UCBHMR3 1-4G33-86 805739MR3 310871MR9 310264MR2 309905MR8 RADNETMR621 00001204FMM04G 559734VIMR1 000005373011-3 RADNETMR598 N/A 720848MR4 N/A 720848MR3 311108MR5 303492MR 00001118FMM0WE 303604MR2 00001309FMM09E 720854MR 00000000UA0472 719365MR Missing_SN_GON4077136 303837MR2 309815MR9 970624MR1 310950MR1 860446MR750W 00001251FMM00R 202966MR3TW Missing_SN_GON4231312 561955MR1 00001309FMM097 386FNSBMR3T 00001308FMM042 954355MR750W 1309FMM09F 904483MR3T 00000000UA0465 305665MR750W 00001204FMM057 305461MR1 00001140FMM0FG 407SMSLMR1 00001147FMM0E5 386FHPCMR3T 00001223FMM08M 561844MR1 N/A 706787750DV 00001236FMM04Y 912819MR 00001301FMM043 671NAVYMR 00001234FMM0KL 671FHPMR750W 310330MR6 808HRAEMR750W 00001204FMM055 808545MR 00001250FMM035 808YMMR 00000306104MR1 808873MR750W 1-4GFG-928 319335MR2 310776MR0 773665SJMR2 PG75W1600017MR 312702MR750 00001250FMM02E 217876DMH3T N/A 847316MR3T 00000305089MR5 708346MR3 00000307816MR9 708346MR4 310973MR3 309655IMRI 00001309FMM094 309655MR750W N/A 815968MR 00001203FMM0VP 815395MR2 00000306062MR1 847872ZMR2 00000309665MR8 317887MR3 00001308FMM03T 317865MR4 00001308FMM006 913322MISHMRW 310253MR0 859334MR 00001221FMM06J 270798MR2 1406NMM0C2 318443MR2 00000307418MR4 225763MR2 00001236FMM051 337289MR1 1236FMM04H 337943MR1 00001251FMM01F BRIGHAM750WMR1 00001227FMM011 BOSTONMEDMR1 MISSING_SN_GON#4350388 508746MR3 00001250FMM03C VAWESTROX750W 00001309FMM085 410328MR3T 00001204FMM04U RADNETMR1652 00000306342MR7 RADNETMR1651 00001203FMM0W2 RADNETMR1635 00000303329MR7 RADNETMR1629 223355 3014643TMR Missing_SN_GON4216878 240707MR3T 00001301FMM047 301570MR 00000000UA0301 RADNETMR1662 N/A RADNETMR6071 N/A RADNETMR1686 00001308FMM046 207MMC3TMR 130FMM07E 734845VA750MR 1442RG01YE 248533750W 00001227FMM00W 616267IMRI 00001134FMM10U 616774MR750W 00001308FMM01H 763795MR1 00000306613MR1 MR229047 00001250FMM01U MR229046 00001308FMM007 MR229048 UA0368 MR229050 00000000UA0091 314577CGMR3T 00000007T5MV12 336832MR750 00001233FMM06K 6033343TW 00001204FMM04E RADNETMR1631 00001203FMM0UK RADNETMR1632 311106MR9 856537MR N/A 732MSKMR 00001251FMM01C 856581MR3T 00000304496MR3 856247MR3 00001233FMM06X 856247MR1 00001227FMM00T 201445750W 911001 775882GBIMR 00001308FMM02E 702382MR750W 00001309FMM065 702731MR750W 310333MR0 RADNETMR1687 PG75W1600002MR 718854MR 00001134FMM10R 71872MR750W 00000122FMM015 RADNETMR1648 310949MR3 631623MR750 N/A 516NS7113T 00001309FMM07F 914750W 00001203FMM0VB EAST750W PG75W1600021MR MSK68MR03 00001308FMM008 MSK68MR7 00000308347MR4 MSK68MR1 00000000UA0363 MSK53MR02 00001140FMM0FT 21277MR1 N/A 212288MR4 00001236FMM04X COR526967 1406NMM058 716740MR1 00000305184MR4 RADNETMR1639 00001308FMM02T 718226MR3T Missing_SN_GON4292927 914631MR 00000305090MR3 330344MR750W 00001308FMM02C 513636MR4 00001111FMM0B2 61456MR5 309752MR4 614293MR9 00001309FMM09G 6142343T 00001250FMM02H 937641MR2 N/A 937208MR1 00001142FMM08Y 405271OUCMR N/A 405636SMR2 1307FMM088 503251PMR3 1406NMM0C5 412914MR 310902MR2 215829MR750W N/A 215728MR3T 00001308FMM032 PRESBYMR1 00001308FMM028 843815750W 00000306781MR6 843750WGEM 00000306801MR2 864529MR 309780MR5 423493MR750W 00001309FMM047 865984MR750 309948MR8 817433HSWMR2 310952MR7 512544SD3T 00001250FMM02W 214645UT3TMR1 00001308FMM02A 2148203TMR N/A 9157473TMR N/A 409772MR6 00000000UA0396 713792AMR14 00001308FMM05P 713798MR1 PG75W1600019MR 713792AMR16 N/A 903236MR750W PG75W1600011MR 713363MR750 00001251FMM01E 210617HUBMR N/A 210WHASC
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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