Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
USPhilips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
Recalling Firm: Philips North America
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 Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
Affected Products
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
Additional Source Details
| Field | Value |
|---|---|
| City | Cambridge |
| State | MA |
| Event id | 98779 |
| Address 1 | 222 Jacobs St |
| Code info | 1. Model Number (REF): 781262. UDI: (01)00884838068445(21)77144. Serial Numbers: 77144. |
| 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.
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🚨 SAFETY ALERT: Philips North America - Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262. Check if your household is affected: https://therecallfile.com/recalls/philips-ingenia-1-5t-cx-with-mr-elastography-mre-1-model-number-ref-78/FDA-Z-1957-2026
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