FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0135-2016
- Recalling firm
- Philips Medical Systems, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-05-05
- Posted
- not on file
- Terminated
- 2016-06-14
- 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 installed which will address the reference line positioning issue with MobiView Should you need to communicate with Philips with regard to this program, please reference FC0781 00431. If you need any further information or support concerning this issue, please contact your local Philips representative or the Technical Support Line: 1-800-722-9377.
- 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 Mexico Netherlands New Zealand Norway Oman Palestine Poland Russian Federation South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom.
- Lot, serial or model codes
- All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software
- 510(k) numbers
- ["K063559","K110151"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28