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U.S. Department of Health and Human Services

Class 2 Device Recall Optima MR430s MRI Scanner

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  Class 2 Device Recall Optima MR430s MRI Scanner see related information
Date Initiated by Firm March 28, 2013
Date Posted May 01, 2013
Recall Status1 Terminated 3 on October 25, 2013
Recall Number Z-1212-2013
Recall Event ID 64885
510(K)Number K103238  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Optima MR430s MRI Scanner; 5000-0002

is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand.
Code Information 08022011-001; 09092011-001;12102011-001;05152012-004;SM11062012-001;02022012-001;08142012-001;04212012-001;05252012-002;12132011-001;SM08292012-007;11052011-002;01192012-001;01132012-001;06282012-010;07252012-001;01022012-001;11202011-001;08142011-001;06302011-001;09172011-001;10082011-001;10172011-002;03142012-007;06142012-001;06212012-001;07172012-001;07232012-001;SM09132012-003;02042012-001;01132012-001;07172011-001;09062011-001;09242011-001;SM10122012-003;M12102012-003;05102012-004;08022012-003;07302012-008;SM01072013-005;05032012-004;08032012-001;10172011-001;SM08152012-001;12262011-001;10092011-001;04172012-001;11052011-001;07112011-001;10242011-007;07222011-001;08102011-001;03092012-001;05172011-001;06222011-001;03202012-004;05182012-001;07112012-002;06092011-001;01232012-001;02162012-001;11262012-007;SM12172012-001;01212012-001;SM10232012-001;11212011-001;12222011-001;SM11132012-002;06012011-001;07132011-001;12042011-001;03062012-007;03282012-001;10272011-009;12142011-001;10302012-006;02112012-001;03062012-008;01272012-001;05162012-003;03262012-002;11292011-001;06112012-004;10172012-001;12102012-001 
Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact Gwen Braeger
Manufacturer Reason
for Recall
Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
FDA Determined
Cause 2
Process control
Action GE Healthcare sent an Urgent Medical Device Correction letter dated April 23, 2013, to all affected customers. The letter informed customers of a potential safety issue due to leakage from gradient coolant lines. Consignees were instructed to monitor the floor for leakage and continue to use if leakage is not observed. If leakage is observed consignees are instructed to stop using the system and notify their local service representative. GE Healthcare will correct all affected scanners by providing an update at no cost. Customers with questions were instructed to contact their local service representataive. For questions regarding this recall call 262-513-4122.
Quantity in Commerce 81
Distribution Worldwide Distribution - USA including AL, CA, CO, FL, ID, IL, MA, NH, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI; Worldwide: Argentina, Australia, Austria, Brazil, Canada, Chile, Denmark, Egypt, Finland, Germany, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Peru, Poland, Russia, Singapore, South Africa, Spain, Sweeden, Switzerland, UK, Ukraine, and UAE.
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