Recall Z-1927-2016 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
| Date | Jun 8, 2016 (initiated May 9, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 97 |
| 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 P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080048 | MSK EXTREME MR SCANNER, MODEL AA5000 Oni Medical Systems, Inc., Feb 6, 2008 |