Recall Z-0325-2016 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems, Inc.
Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.
| Date | Nov 23, 2015 (initiated Aug 21, 2014) |
| Status | Terminated |
| Reason | When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultant image order is reversed. This occurs with software release R5.1.7/R5.1.8. |
| Root cause | Software Design Change |
| Action | Philips Healthcare sent an Customer Information Letter dated July 2014, on August 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips will issue a Field Change Order to install updated software in a Service Pack that makes the slice numbering consistent for fused and unfused images. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377 |
| Quantity | 307 units |
| Distribution | Worldwide Distribution - USA (nationwide) and to the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Denmark Estonia, Ethiopia. France, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Korea, Republic of, Libya, Malaysia, Mexico, Ne |
| FDA record | Open on fda.gov |