FDA · Medical device recall

GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System… and 2 more products

Jan. 31, 2008

Date posted by the FDA: Jan. 31, 2008
Status: Terminated
Filed by: GE Healthcare
Reason: Frozen Image Problems: During an acquisition (fluoro and/or record), there have been cases reported where an image became "frozen" on the DL (digital leader acquisition system) live monitor screen. In such cases, the system continued to send out X-rays without reporting an error message. The result was that the live imaging screen displayed an older "frozen" image until the operator released the
Distribution pattern: Worldwide-USA including states of AR, CA, CO, FL, GA, IL, IN, LA, MA, MD, MO, NC, NJ, NM, NV, SC, TN, TX, WA, WI, AK, AL, AZ, ,CT, DE, HI, ID, KS, KY, ME, MI, MN, MS, MT, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, UT, VA, WV, and Puerto Rico and countries of Hungary, Korea, Algeria, Argentina, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Czech Republic, Dominican Republic, Finland, France, Georgia, Germany, Great Britain, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Morocco, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Singapore, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Turkey, and Venezuela.

3 products in this recall

GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System…

Product: GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
Quantity: 378
Codes and lots: 600010VA01 HU1094VA01 HU1116VA01 HU1205VA01 0850060723 DZ1006VA01 0910162009 0910162010 0910162011 0910162012 0910163011 0910163014 0910162013 0910162013 010120RX44 0002673668 604875AINNOVA1 416480INNOVA 604682INNOVA1 604682INNOVA2 604875AINNOVA2 26814ANGI2 082416100014 082416150002 082416100011 082416130026 082416010005 082416010007 082416030005 082416040011 082416040012 082416040014 082416050003 082416060001 082416070006 082416100009 082416100012 082416100017 082416120008 082416130016 082416130019 082416130023 082416130024 082416160007 082416180003 082416200004 082416210007 082416220010 082416120009 2664023INNOVA CS1118VA03 CS1006VA04 FI1017VA02 FI1017VA03 FI1025VA01 A4166952 B1650215 B5483438 M1334109 M2068110 M2569315 M2844529 M4176519 M4183841 M4200108 M4211066 M4496941 B4192944 M2621511 HC4348XR02 PC0052XR07 PC0052XR08 507902XR01 HC0222XR35 HC4355XR06 00060VAS02 00159VAS04 00192VAS04 00192VAS05 00234VAS01 00282VAS02 00371VAS01 00440VAS02 00440VAS03 00463VAS06 00888VAS02 01065VAS01 05208VAS02 05217VAS02 05451VAS01 10507VAS01 00197VAS01 H2077VAS27 0828160007 0002644132 08301600206936 083016002101586 083016102100795 083016202101036 083016202101917 083016242100936 083016282101457 083016602101386 083016802100516 083016802100866 083016802100916 083016862101407 083016862101656 083016862101916 83016802100337 83016862100377 083016602101807 083016802101197 "08301680520687 (temp 0002673438)" 083016822101187 0835160017 0835160018 IE1100VA02 A5333036 A5333037 A147111802 A5125125 A5129025 A5131858 A5155141 A5164510 A5219606 A5220710 A5286803 A5400910 A5605743 A5624112 A5800506 A5807919 A58080104 B5120723 B5219603 C5123625 C5123626 C5323515 A5624127 YV0053 YV0054 YV0057 YV0058 YV0059 YV0060 YV0061 YV0062 YV0063 YV0064 YV0065 YV0066 YV0067 YV0068 YV0069 YV0070 YV0071 YV0072 YV0073 YV0074 YV0075 YV0076 YV0077 YV0078 YV0079 YV0080 YV0081 YV0100 KW1018VA05 KW1018VA01 KW1018VA02 KW1018VA03 LV4000VA02 LV4000VA03 LV4001VA02 LT4000VA04 0002679402 0002684003X 644INNOVA21 83INNOVA2588441 MA1004VA02 NO1009VA03 600151VA01 600042VA03 PER00218 0002674834 787844INNOVACL1 787844INNOVACL2 787844INNOVACL3 SA1011VA01 SA1054VA02 0847160002 0847160003 FEB52055 ME612436 CEE15663 SD1038VA01 A004RX01 A020RX13 468668XR01 SY1001VA02 SY2005VA01 0853060191 853060197 06052VAS01 20001VAS02 34009VAS06 34134VAS02 35049VAS01 58010VAS01 80002VAS01 505848CATH1 505848EP 318448INNOVA3 305682IN2 4105502100 410554INNOVA2 208367INNOVA 208381CCL1 2035762100 717217CA10002 843797TCL1 214947MINNOVA 214947MINNOVA2 PRESBYDEP 303839CL2 252384CATH1 303788CL1 4436432100 4107872100 8184092100 864255SFCL2 219932DCL2 305364P2100 954987CL4 713794LAB1 727869CATH3 727869CCL2 727869EP5 208227CATH1 8157412100 816861KCVAI2 308865GIN1 865693CCL 865693CCL2 608775NOVA2 0002507622 310825INNOVA21 516562INNOVA6 516562INNOVA7 865977CCL 217383CCL2A 541732CV2 0002698287 0002698301 251435ICV3 239436CATH4 732776CATH4 212305CATH1 212604INNOVA1 65049321 65049321 304424INNOVA 610983INNOVA2 201447LAB1 215453INNOVA21…
Recall started: Nov. 15, 2007
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Device Design
What the company told customers: Customers were contacted by means of an Urgent Medical Device Correction Letter on November 9, 2007. The letter described the product and the safety issue. The letter also made short term recommendations and described a long term solution, which is pending as an expected hardware and/or software modification that will be made at no cost. Short Term Recommendation: Take extra care when working with motionless anatomy or devices where there is little evident motion to warn you of the frozen image occurrence. Always completely shut down and restart the system (not just reset) immediately after such an error occurs. Also, please immediately report this issue to your local GE Healthcare field service engineer.
Recall number: Z-0690-2008

GE Innova 3100 / 3100 IQ…

Product: GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
Quantity: 320
Codes and lots: HU1099VA04 0850060719 0850060724 0850060726 0850060727 0850060728 378INV31 0910064009 0910163012 0910163013 0910163015 BE5003VA02 140024RX09 BA4080VA01 2573329 2667313 BG4549VA02 082416040018 082416140004 082416290001 082416140003 082416130018 082416080001 082416010006 082416020004 082416020005 082416030006 082416040015 082416040019 082416100013 082416110002 082416110003 082416120010 082416140002 082416150001 082416160008 082416160009 082416160013 082416180004 082416190004 082416190001 082416190002 082416190003 082416210006 082416210008 082416220008 082416270002 082416300001 082416310003 082416310006 082449100050 082416160011 082416160012 082416170002 082416040017 082416070004 2625365INNOVA 2645993INNOVA CS1006VA03 0002655786 M2030709 M4163030 M4166988 M5480755 M6083613 A6017504 GE1005VA01 HC4348XR01 HC1536XR04 00203VAS01 01367VAS02 A5127281 A5112597 A5162256 A5333035 A5812244 B5274834 B5332001 B5810907 YV0036 YV0162 YV0048 YV0163 XF0250 YV0033 YV0034 YV0035 YV0038 YV0039 YV0040 YV0042 YV0043 YV0044 YV0045 YV0046 YV0047 YV0049 YV0050 YV0051 KW1055VA01 0834160003 83INNOVA1188379 0920169007 2048000INNOVA 2664627INNOVA PL1082VA01 600098VA01 RU2457VA01 RU1482VA02 RU1475VA01 RU1550VA01 MPX82206 FPG86403 FPG93008 DPM32143 DPN88402 0853060194 01012VAS01 41018VAS01 58002VAS01 60001VAS01 215576INNOVA1 518525LAB1 760242CATH1 404686CRI3 4103623100 281420LAB23100 541382CV3 205783BCL5 540953INNOVA 2035763100 508941IN1 717217INN31 843797TCL2 573815BCR1 361980INNOVA2 214590PH3100 313593IC2 561266IN31 303629CL4 303629EP 3027443100 7018573100 303788CL2 812450EP1 239939CLA 850862IN3100 352333CATH1 352333CATH2 8184093100 919731WMINOV 305364P3100 205877CCL1 808547QCV2A 281440CL3 208227CATH2 2014183100 7028533100 865693CCL1 765453INNOVA1 609757IN3100 6619483100 219326IN31 7022333100 816969LSCATH 209334LINNOVA1 310319SM3100 502587LAB1 219877IN31 9734293100 215335INNOVA1 239436CATH3 239513CRLAB1 8053703100 615222H 812858GWLAB1 812858GWLAB2 8014793100 270688INN 65049331 850747BR3100 6106483100 8508573100 850469BCV1 8508573100 ECXV1406C 413447CATH BPINNOVA3R 207662CL4 207879CL131 770991CL3 951788INNOVA3 951788INNOVA2 541677MINNOVA1 5033703100 417269SCLD 7278253100 253968INNOVA 254742KDCL1 662377CV4 412437INNOVA 9202623100 8019643100 303425CL4 2197573100 0002595303 228818VASC 316651INNOVA31 316962WCVC1 316962WCVC2 325428CATH1 325428CATH3 336832MCPV 360456XCL3 361857CATH1 405272SCL2 405372S3100 405604D3100 405840OIC3100 406447VAIN3 406543IN3 413582C3100 414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 417885JCL7 417885JCL8 423495MCL6 423844CCL1 478274CTH1 502852INNOVA 510797INV8 512901NI3100 516562INNOVA8 516562INNOVA9 516663INNOVA1A 530244XC106 561548CL4 570476INNOVA31 573458CL1 573632CRC2 6012883100CV2 603421PCL 610595CL1 610770INNOVA31 610983INNOVA1 616392INNOVA 617732IN9 618241GSI3100 620225INNOVA31 631968INNOVA2 631968INNOVA3 662377CV2 671GMHAINVA 708WESTSUB3100 713359INC 713948INA 717782INNOVA31A 718245UNITY 718470INNOVA2 718780CATH2 732776CATH6…
Recall started: Nov. 15, 2007
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Device Design
What the company told customers: Customers were contacted by means of an Urgent Medical Device Correction Letter on November 9, 2007. The letter described the product and the safety issue. The letter also made short term recommendations and described a long term solution, which is pending as an expected hardware and/or software modification that will be made at no cost. Short Term Recommendation: Take extra care when working with motionless anatomy or devices where there is little evident motion to warn you of the frozen image occurrence. Always completely shut down and restart the system (not just reset) immediately after such an error occurs. Also, please immediately report this issue to your local GE Healthcare field service engineer.
Recall number: Z-0691-2008

GE Innova 4100 / 4100 IQ…

Product: GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
Quantity: 171
Codes and lots: 0850060718 0850060720 0850060721 0850060722 0850060725 514842AINNOVA 613548INNOVA3 082406070010 082406310005 082416030007 082416040020 082416100016 082416130020 082416130021 082416130025 082416220006 FI1015VA02 M1230007 HC0220XR07 00490VAS02 01278VAS01 10091VAS01 083006202101017 IE1100VA01 IL1043VA01 A5102671 A5163317 A5605732 XF0150 XF0151 XF0152 XF0153 XF0154 XF0155 XF0200 YV0006 YV0007 XF0156 YV0009 KW1001VA03 KW1001VA04 KW1018VA04 LB1037VA01 600042VA02 600152VA01 RU2714VA01 RU2992VA01 RU1050VA03 SA1005VA06 0002603739 0002603828 3184734100 706774USP3 6309784100 6616324100 304256INNOVA 2035764100 352596SPEC 423495MSPEC2 5135844100 719560INN41 303320OR41 303399IR 303436ANGIO 3027444100 574294IN41 804594CATH 239939INNOVA 574535IN41 252847PRS3 864255SF4100 305823IN4100 7137764100 3016094100 414649CL2 812858GWSP 212639ACT1 8014794100 304424CCINOVA 309655FSP1A 4134474100 5033704100 509474SH41 813745INTV 813972INTV 201541SP1 229228INNOV41V 281401T4100 918744JR4100 22925941V2 586573SP1 SHOWCASE4100 508856OR41 314569SJRM12 314966DPHSP 317887INNOVAPV 330489SPEC9 352333INVOR 386254HS1 386254HS2 386HPOS1 404466SF41A 404GHSIR1 410337INNOVA2 412647OR10 414649DVI 419696LAB1 505848CATH2 505848V4100 508650IN41 509482HFI 512901NI4100 530888ANG206 541686SPR1 561548VAS2 570321LAB2 605333RM10 610988INNOVA4 617636IN1 619229INNOVA1 623848SP 630275G41 630275G41B 650493ANGIOCT 662244GTSP 678EJCIR1 706291RINN2 706651SP1 706733SP1 708783CL4100 708783SP4100 713375U4100 718630LIBERTY 727791INNOVA 770535N4100 803256SP 804594ANGIO 812238UN41 812825INNOVA1 813615CL10 815740SC4100 817465AR4100 817922BA4100 843577CL2 845368RM10 850747IN4100 863687INV24 864573LAB2 865373SP 865481SUR 908522SP1 915577SP1 918682IN41 954MW4100 970247INNOVA COR359867 DR4100 FHORL4100 PEMBROKE4100 RADNETXV1 RHD4100 480512SP 8458584100 770736SP1 423495M4100E 423493I4100 8593134100 313343SP1 708202VA41 708WESTSUB4100 and 509575YM4100
Recall started: Nov. 15, 2007
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Device Design
What the company told customers: Customers were contacted by means of an Urgent Medical Device Correction Letter on November 9, 2007. The letter described the product and the safety issue. The letter also made short term recommendations and described a long term solution, which is pending as an expected hardware and/or software modification that will be made at no cost. Short Term Recommendation: Take extra care when working with motionless anatomy or devices where there is little evident motion to warn you of the frozen image occurrence. Always completely shut down and restart the system (not just reset) immediately after such an error occurs. Also, please immediately report this issue to your local GE Healthcare field service engineer.
Recall number: Z-0692-2008

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

Source: FDA · Medical device enforcement reports, recall numbers Z-0690-2008, Z-0691-2008, Z-0692-2008. The agency record governs; check it and the company before acting.

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