Events

Recall of Device Recall GE Healthcare, SIGNA HD 3.0T

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72301
  • Event Risk Class
    Class 2
  • Event Number
    Z-0257-2016
  • Event Initiated Date
    2015-08-31
  • Event Date Posted
    2015-11-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140633
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Reason
    When performing head or neck scans, the currently displayed sar values could be lower than the actual sar in the head as predicted by sar modeling. the predicted head sar value from the modeling suggests the actual sar in the head could exceed iec60601-2-33 limit of 3.2 w/kg for some scans.
  • Action
    GE Healthcare sent an Urgent Medical Device Correction letter dated August 31, 2015. The letter was addressed to Hospital Administrators/Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall GE Healthcare, SIGNA HD 3.0T
  • Model / Serial
    002005-1018-15 352333MR3T 000006-0523-13 716859MR3T 00001003BD6425 352376MR3T2 00000280001MR9 MR129031 00000285499MR0 2154563TMR 000000HDMR3702 RADNETMR554 00000274930MR7 805CHLIMR1 00000280057MR1 513558MR3T 00000274998MR4 213977MR2 002004-0713-06 ACB41109MR 002004-0406-08 323442MR2 002004-0406-15 323442MR1 00000273396MR2 7326133T 002004-1115-19 865373MR1 002005-0316-05 7576713T 0002005-0606-4 205750MR2 00000274839MR0 9287573TMR 002006-0119-15 559325CIIMR1 0002005-1201-3 256734MR3T 002005-1003-15 201487MR 000000HDMR2996 6053223TMR 000000HDMR3245 775RDC3T 002005-0620-16 405634S3T 00000269460MR2 602406IMR 00000275670MR8 813972VAMR 0002005-1121-7 480614MR1 00000273230MR3 602689MR1 002005-1201-20 601288MR3T 00000275936MR3 ALLIANCESIG463 00000275086MR7 650306SMR3T 00000275162MR6 772VRAMR3T 00000273459MR8 360397MR2 0002005-0104-5 662841MR4 000006-0511-20 336852SEMR 00000278626MR7 228KAFBMR3T 00000278619MR2 806212MR3T 00000278722MR4 337261MR1 00000281703MR9 916DR3TMR 0002005-0511-5 203797MR3T 002005-1115-04 615342MR3T 00000282868MR9 504873TMR3 00000281682MR5 859275MR3T 000000HDMR5653 RADNETMR608 00000000036657 480584MR1 #N/A TRAINING789 N/A 201669MR2 00000278623MR4 972378NSC3TMR1 00000267322MR6 920568MR3T 00000273365MR7 503280MR2 0002005-1201-6 865541MR3T 00000086257DP3 901516U3T 00000264748MR5 0910277003 00000268123MR7 0910272046  AZ1003MR02 00000282790MR5 082427090245 00000285380MR2 082427100084 00000286559MR0 082427090090 00000286800MR8 082427100089 00000287879MR1 082427040076 00000288667MR9 082427070050 00000289798MR1 082427100093 00000261198MR6 082427210039 00000262803MR0 082427070034 00000262931MR9 082427040047 00000265593MR4 082427160041 00000266147MR8 082427040061 00000267973MR6 082427040052 00000270974MR9 082427100064 00000271233MR9 082427040046 00000272894MR7 082427140039 00000273229MR5 082427120044 00000277189MR7 082427160049 290392MR0¿¿¿¿¿¿¿¿¿¿ 082427270017 00000265589MR2 DK1083MR04 00000000WB0692 ET1009MR01 00000262460MR9 0828270021IB01 00000270245MR4 0828270023 00000272433MR4 083027002101706 N/A 083027202101396 00000275668MR2 IR1503MR01 00000279077MR2 KW1004MR03 00000262791MR7 56MRE3TH2565370 00000280669MR3 0920279025 00000309597MR3 NO1011MR01 00000272533MR1 787840CIRT3T 00000276591MR5 787653MR3T 00000279460MR0 787740MR3T 00000275845MR6 RU1283MR01 00001002BD637F MEX68900 00000HDMR10201 GP178328 00000275642MR7 GEE34040 000000000WB658 MPX10000 00000266820MR0 387040MR06 00000262456MR7 34208MRS01 00000271120MR8 34006MRS03 00000266270MR8 10146MRS03 00000274693MR1 3882630908MRMET
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US: Nationwide including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA.
  • Product Description
    GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR safe biopsy needles.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Manufacturer Address
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA