Device product
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.
Z-0135-2016
Product summary
- Event
- Event 68228
- Status
- Terminated
- Classification
- Class II
- Quantity
- 317
- Official record key
device-enforcement:Z-0135-2016
Official wording
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.
Code information: All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software
Distribution pattern: 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 Mexico Netherlands New Zealand Norway Oman Palestine Poland Russian Federation South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom.
Derived failure modes
-
Unknown
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.