Z-0196-2016Class II

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

Name: Z-0196-2016 MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
Creator: GE Medical Systems, LLC
Published: 2015-09-23
License: https://open.fda.gov/license/

GE Healthcare / initiated 2015-09-23 / Terminated / root cause: manufacturing process

FDA source

GE Medical Systems, LLC began a recall of MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS on 2015-09-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0196-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-23
Posted: 2015-10-30
Terminated: 2016-03-28
Recalling firm: GE Healthcare
Product: MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0196-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0196-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-10-30

Product code LNH

K043262Class IIGe Signa Excite Mr Surgical OptionGE Healthcare / cleared 2005-01-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)