FDA DevicesClass II
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model N...
Published: May 6, 2026Recall ID: Z-1966-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
Affected Products
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
Additional Source Details
| Field | Value |
|---|---|
| City | Cambridge |
| State | MA |
| Event id | 98779 |
| Address 1 | 222 Jacobs St |
| Code info | 1. Model Number (REF): 782145. UDI: (01)00884838108684(21)17385. Serial Numbers: 17385. |
| Postal code | 02141-2296 |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 1 unit |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260414 |
| Initial firm notification | Letter |
| Center classification date | 20260427 |
Overview
- Recalling FirmPhilips North America
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.