—#141038

Product

MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K043262
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2015-09-23
Posted by FDA: 2015-10-30
Terminated: 2016-03-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141038. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.