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.
FDA Recall Z-1212-2013 · Posted 2013-05-01
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2013-03-28
Date Terminated2013-10-25
Product Quantity81
Reason for Recall
Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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