Philips SmartPath to dStream for XR and 3 — Class II medical device recall Z-1967-2026
Ongoing recall by Philips North America, reported 2026-05-06, distributed nationwide. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in c
| Recall number | Z-1967-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2026-04-14 |
| Classified | 2026-04-27 |
| Reported by FDA | 2026-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BD, BE, BR, CA, CH, CL, CY, DE, DK, EC, EG, ES, FR, GB, GR, HK, ID, IL, IN, IQ, IR, IT, JP, KE, KR, LB, LT, MT, MX, NL, PE, PK, PL, PT, SE, SG, TH, TN, TR, TW |
| Quantity | 14 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838095083, 00884838098909 |
| Serial numbers | 17356, 17384, 17386, 24058, 24066, 34211, 34223, 38066, 38109, 38111, 38113, 38117, 38356, 74011 |
| Model numbers | 781270, 782113 |
Product
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
Reason for recall
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
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-1967-2026. 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.