All Philips Ingenia — Class II medical device recall Z-0135-2016
Terminated recall by Philips Medical Systems, Inc., reported 2015-10-28, distributed in AL, AR, AZ, CA, CO, FL, GA, IL…. In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases,
| Recall number | Z-0135-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2014-05-05 |
| Classified | 2015-10-19 |
| Reported by FDA | 2015-10-28 |
| Terminated | 2016-06-14 |
| Distributed | AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, MA, MI, NY, OH, OR, PA, SC, TX, VA, VT, WA |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BR, CA, CH, CL, CN, CO, DE, DK, EC, EE, ES, FR, GB, ID, IE, IN, IQ, IT, JO, JP, KR, MX, MY, NL, NO, NZ, OM, PL, SE, TR, TW, ZA |
| Quantity | 317 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0135-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.