Recall Z-1212-2013 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
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.
| Date | May 1, 2013 (initiated Mar 28, 2013) |
| Status | Terminated |
| Reason | Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard. |
| Root cause | 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 |
| Quantity | 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, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103238 | 1.5T OPTIMA MR430S Ge Medical Systems, LLC, Feb 11, 2011 |