Recall Z-1433-2011 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
10) Brivo MR355/Optima MR360 Not yet 510(K) cleared and are not distributed in the US. (K103330) The Brivo MR355/ Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, paramet
| Date | Feb 24, 2011 (initiated Nov 9, 2010) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential issue associated with the gradient cables being inadvertently swapped while servicing the gradients on some GE Healthcare MR Systems that may impact patient safety. If the gradient cables are inadvertently swapped while servicing the gradients, and the Service Engineer does not perform the geometry check as required in the service procedure, images m |
| Root cause | Nonconforming Material/Component |
| Action | On November 9, 2010, the firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated November 5, 2010 to all Consignees/Customers. The letter described the product, problem and action to be taken by the firm. GE instructed the customers to contact their local GEHC support Engineer, if they have any questions about the image orientation, or the procedures for geometry checks on thier system. Additionally, a GE Healthcare representative will install a device, which will reduce the potiential for the gradient cables to be swapped. Contact your local GEHC Support Engineer if yo |
| Quantity | 67 |
| Distribution | Worldwide distribution: USA including DC and PR; and countries including: VIET NAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKEY, TUNISIA, FORMER YUGOSLAV REPUBLIC OF MACEDONIA, THAILAND, TAIWAN, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103330 | BRIVO MR355, OPTIMA MR360 Ge Hangwei Medical Systems Co., Ltd., Feb 11, 2011 |