Z-0135-2016Class II

All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software...

Name: Z-0135-2016 All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software...
Creator: Philips Medical Systems, Inc.
Published: 2014-05-05
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-05-05 / Terminated / root cause: software

FDA source

Philips Medical Systems, Inc. began a recall of 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... on 2014-05-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0135-2016
Classification: Class II
Status: Terminated
Initiated: 2014-05-05
Posted: 2015-10-19
Terminated: 2016-06-14
Recalling firm: Philips North America LLC
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.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: 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 tag: software
FDA 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 in commerce: 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.
Product codes and lots: All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0135-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0135-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-19

Product code LNH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)