FDA Device recall Z-0135-2016
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software
- FDA Device
- Class II
- terminated
- Published 2015-10-28
On 2015-10-28 the FDA classified a Class II recall of All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software by Philips Medical Systems, citing 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 line….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0135-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-05 |
| Published | 2015-10-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems |
| Distribution | AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, MA, MI, NY, OH, OR, PA, SC, TX, VA, VT, WA |
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.
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.
Identifiers
| code_info | All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0135-2016%22
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