Ingenia — Class II medical device recall Z-0325-2016
Terminated recall by Philips Medical Systems, Inc., reported 2015-12-02, distributed nationwide. When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultan
| Recall number | Z-0325-2016 |
|---|---|
| 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 | 2014-08-21 |
| Classified | 2015-11-23 |
| Reported by FDA | 2015-12-02 |
| Terminated | 2021-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BR, CA, CH, CL, DE, DK, EE, ES, FR, GB, HK, ID, IE, IN, IQ, IT, JO, JP, KR, MX, MY, NL, NO, NP, NZ, OM, PE, PL, SA, SE, TR, TW, ZA |
| Quantity | 307 units |
| Reason classes | software |
Product
Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.
Reason for recall
When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultant image order is reversed. This occurs with software release R5.1.7/R5.1.8.
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-0325-2016. 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.