Recall Z-0135-2016 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems, Inc.
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities.
| Date | May 5, 2014 |
| Status | Terminated |
| Reason | In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases, where MobiView fused Images are used to show the cross reference lines, the cross reference lines may be positioned incorrectly. |
| Root cause | Software design |
| Action | Consignees were notified of the recall by letter sent May 2014. They were instructed to do the following: Do not perform planning or review planning of transversal images on fused sagittal images which were generated through Mobi View postprocessing Instead, review the planning of transversal scans only on the unfused stations. A Field Change Order with reference FC0781 00431 is being released that PHILIPS requires Philips field service engineers to disable the MobiView post processing software. When possible this will be done remotely. Once it becomes available, a software update will be i |
| Quantity | 317 |
| Distribution | Worldwide Distribution-US: AL AR AZ CA CO FL GA IL IN KS KY MA MI NY OH OR PA SC TX VA VT WA OUS: Argentina Australia Austria Bangladesh Belgium Brazil Canada Chile China Colombia Denmark Ecuador Estonia Ethiopia France Germany India Indonesia Iraq Ireland Italy Japan Jordan Korea, South Malaysia Me |
| FDA record | Open on fda.gov |