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U.S. Department of Health and Human Services

Class 2 Device Recall MR Surgical Option for GE 1.5T and 3.0T MRI Systems

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  Class 2 Device Recall MR Surgical Option for GE 1.5T and 3.0T MRI Systems see related information
Date Initiated by Firm September 23, 2015
Date Posted October 30, 2015
Recall Status1 Terminated 3 on March 28, 2016
Recall Number Z-0196-2016
Recall Event ID 72448
510(K)Number K043262  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS.

UPDATE 11-4-2015: Model M0001SS
Code Information Mfg Lot or Serial # System ID 00000304124MR1 904202MR8 00000000UA0116 330344MR750W 00000000UA0117 616267IMRI UA0326 614293MR9 00000307553MR8 415UCBHMR1 00000000UA0296 309655MR750W 00000000UA0396 713792AMR14 00000012228M63 608263MR4IOR N/A 614RMHTMR1 N/A 720848MR4 N/A 309655IMRI 00000299229MR5 AH5824MR01 00000014131M67 MRHM0323 00000018480M64 MR307144MR6 00000021158M61 MRHM0885 00000013254M68 082445160014 00001309FMM07L T4185506 DUMFMI60876024 M347028301 00000021695M62 M4194477 00000305145MR5 UC2547MR01 00001219FMM0H1 EM0105 00001105XF5047 PL2853MR01 00001251FMM044 34368MRS01   UPDATE 11-4-2015:  Mfg Lot or Serial # System ID 2 602406IMR 3 507284NMRV N/A 214820ITABLE N/A 416369MR3T 000000PTST0008 082427040101 000000PTST0007 082427050024 000000PTST0003 CS1020MR01  N/A CS1006MR03 4 YM1733  000000PTST0010 YM3833 000000PTST0006 ZA2169MR01 000000PTST0005 10590MRS01 
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 GE became aware of an issue with the table transfer release mechanism of the MR Surgical Suite Option. The issue may prevent patient transfer between the MR and surgical tables.
FDA Determined
Cause 2		 Process control
Action GE sent an "Urgent Medical Device Correction" letter dated September 23, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You may continue to use the table. Monitor for any issues in releasing the table. If you see this issue, contact a GE Field Engineer. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 23 (11 US; 12 OUS) Update 11-4-2015: 35 (14 US; 21 OUS)
Distribution Worldwide Distribution - US Distribution including the states of : CA, CO, FL, IL, MI, OH, TX and WI., and to the countries of : AUSTRIA, BRAZIL, FRANCE, GERMANY, JAPAN, POLAND and TURKEY. UPDATE 11-4-2015: Additional states: AZ, MN. Additional countries: Canada, China, Czech Republic, South Africa, and United Kingdom
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 = GE HEALTHCARE
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