FDA Device recall Z-1967-2026
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113 by Philips North America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1967-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-14 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips North America |
| Distribution | US |
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
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.
Identifiers
| code_info | 1. Model Number (REF): 781270. UDI: (01)00884838095083(21)38109, (01)00884838095083(21)17386, (01)00884838095083(21)383…1. Model Number (REF): 781270. UDI: (01)00884838095083(21)38109, (01)00884838095083(21)17386, (01)00884838095083(21)38356, (01)00884838095083(21)34211, (01)00884838095083(21)38113, (01)00884838095083(21)17356, (01)00884838095083(21)38111, (01)00884838095083(21)74011, (01)00884838095083(21)24058, (01)00884838095083(21)24066, (01)00884838095083(21)34223. Serial Numbers: 38109, 17386, 38356, 34211, 38113, 17356, 38111, 74011, 24058, 24066, 34223. 2. Model Number (REF): 782113. UDI: (01)00884838098909(21)38066, (01)00884838098909(21)38117, (01)00884838098909(21)17384. Serial Numbers: 38066, 38117, 17384. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1967-2026%22
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