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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, SIGNA Excite 3.0T

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  Class 2 Device Recall GE Healthcare, SIGNA Excite 3.0T see related information
Date Initiated by Firm August 31, 2015
Date Posted November 10, 2015
Recall Status1 Terminated 3 on September 07, 2018
Recall Number Z-0256-2016
Recall Event ID 72301
510(K)Number K040444  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.
Code Information 00000304469MR0 910609CF3T 00000000043586 336713WFUMR 002004-0924-11 321MR3T3 2333 901726OPMR 002004-0520-05 727785MR 00000005232YR4 414649MR5 000000HDMR2722 858657MR1 1556044 9085223T 002004-0520-06 407999MR3T 002004-0805-01 8109873T 00000263655MR3 321MR3T2 00000006583YR9 HSS3T5 002005-0216-15 731425MR2 002005-0216-19 6053883T 002005-1020-30 248465MR3T 002005-0127-12 248849MR3T 002004-1117-11 916UCDMR3T 000000HDMR3737 2059393T 002005-0331-11 919684MR6 000000HDMR3654 402219MR3T 002005-0519-19 205345MR3T 000000000R3780 210921SWGMR 002005-1201-36 662MSU3T 000000HDMR5675 407303MR3T 00000267527MR0 903870VM3TMR1 000000HDMR5786 602285MR4 00000HDMR10672 ASLWEST30MR 00000269041MR0 0910272044 00000266160MR1 2550000 00000257756MR7 082427230015 00000279423MR8 082427310015 00000280319MR5 082427160051 00000280898MR8 082427100075 00000282686MR5 082427010032 00000283076MR8 082427300008 00000283386MR1 082427070048 00000265969MR6 082427040042 00000279752MR0 082427160050 00000273833MR4 M4434864 00000264643MR8 M4135138 00000838BD4EC9 A5103135 00000273267MR5 YM1408 00000267200MR4 YM1396 00000267203MR8 YM1397 00000268417MR3 YM1414 00000269575MR7 YM1403 00000270026MR8 YM1405 00000272070MR4 YM1407 00000272969MR7 YM1406 00000260692MR9 0850270170 000000HDMR3167 81MR3T2715363 00000013212GQ6 7771MREXCITE3 00000254375MR9 NPV26104 00000266826MR7 0853270071 00000269581MR5 0853270072 
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 55
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = GENERAL ELECTRIC CO.
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