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U.S. Department of Health and Human Services

Class 2 Device Recall Optima 1.5T MR430s

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  Class 2 Device Recall Optima 1.5T MR430s see related information
Date Initiated by Firm May 09, 2016
Date Posted June 08, 2016
Recall Status1 Terminated 3 on July 11, 2018
Recall Number Z-1928-2016
Recall Event ID 74215
510(K)Number K123068  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Optima 1.5T MR430s MR Scanner, a diagnostic imaging device
Code Information 0001272012-001 615VEMR 0003062012-008 605328SMR15 0012102012-001 SMRDEMO01 0005162012-003 801243MR2 SM05132013-001 970879MR430 SM10172011-004 509482MR3 SM06142013-001 641428ONI SM10302012-006 ARIA430S SM06272013-006 207OA430MR SM11262012-007 USOTCSMR SM07082013-012 719766SMR 0SM5312013-001 760725MR1 SM08152013-002 703805ONIMR4 SM11252013-001 310665MR 0000SM09202013 208557MR2 SM05212013-004 VAD430 SM11132012-002 856581MR430 SM12172012-001 303577MR2 0001212012-001 786308MR1 0012222011-001 973586MR 0006012011-001 SINAI601 0007132011-001 516482MR430 0012042011-001 MKMG430S 0 02162012-001 805679ONI 0012142011-001 215DOY430S 0006112012-004 360786ONIMR 0003062012-007 212288ONI 0010272011-009 513636NICMR 0003282012-001 518453MR2 0002112012-001 803434ONI Missing_SN_GON4194272 402EXTMR SM03132014-002 H430SMR SM05142014-006 520VAONIMR SM07182014-009 352376ONI1 SM11062012-001 MRSM11062012001 0002022012-001 0910272081 0004212012-001 514697ONI SM01232014-003 SM01232014-003 SM05192014-003 MRSM05192014003 0005252012-002 MRMEDSMR3 SM02252014-003 082427010079 SM03292014-007 082427020055 SM05272014-007 082427020060 SM09202013-017 082427040145 0SM0225013-004 082427030080 SM06202013-002 MRSM06182013002 SM01202014-014 DK1000MR04 SM10242013-002 DK1075MR01 0000DK1030MR03 DK1030MR03 0012132011-001 DK1068MR01 0001192012-001 FI1378MR01 0011052011-002 FI1006MR02 SM01102014-001 M24070304 SM01152013-001 L1650217 SM03052014-004 M176430610 SM04152014-001 M5817305 SM04292014-002 M2862820 SM07182014-014 M172471308 SM08152013-003 M4215583 SM12192013-003 M219000205 SM02042014-003 D4185525 SM07182014-008 0828270040 0002042012-001 IS1019MR01 SM10122012-003 A5177233 SM12102012-003 A287971801 0007172011-001 A127292410 0009242011-001 A5725513 SM02132014-001 OM0005 SM03202014-001 OM0004 SM11122013-007 OM0003 SM12202013-001 OM0100 0005102012-004 OM0001 0008022012-003 OM0002 0007302012-008 0850270400 SM07182014-012 KW1019MR04 SM07182014-013 KW1001MR05 0005152012-004 DRD0120 SM07142014-003 GRN0121 SM01072013-005 SM01072013-005 0005032012-004 PL2783MR01 SM04212014-003 PPR74710 0008032012-001 RU1086MR04 SM03062013-001 0847270030 SM07152013-008 0847270032 0010172011-001 0847270028 SM04072014-012 ZA2630MR01 SM08152012-001 ZA2458MR01 SM03142013-002 NPV15969 SM10162013-004 CEZ01534 0003092012-001 MPX19500 0004172012-001 DPN26330 0007112011-001 UP925714 0010092011-001 DPN89106 0010242011-007 UPW01900 0011052011-001 NPV22527 0012262011-001 MPX27417 0008102011-001 N006MR02 SM07182014-007 C001MR02 SM11212013-001 AE1444MR01 0001232012-001 10476MRS01 0008152010-001 0910272078 
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action GE Healthcare sent an " Urgent Medical Device Correction" letter dated May 9, 2016, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Detail, Product Correction & Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 101
Distribution US: AL, AZ, CA, CO, FL, ID, IL, IA,ME, NE, NV,NH, NJ, NY, NC, OH, PA, SC, SD, TN, TX, UT,VA, WA, WI. OUS: Argentina Australia Austria Brazil Canada Chile Colombia Denmark Egypt Finland France Germany Greece Hong Kong Iceland Italy Japan Korea (Republic of) Kuwait Malaysia Netherlands Norway Peru Poland Portugal Russia Singapore South Africa Spain Sweden Switzerland Ukraine United Arab Emirates 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 MEDICAL SYSTEMS, LLC
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