Recall Z-1955-2026
Philips North America · initiated April 14, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.
Codes / lots: 1. Model Number (REF): 782143. UDI: (01)00884838108660(21)42218, (01)00884838108660(21)42225. Serial Numbers: 42218, 42225. 2. Model Number (REF): 782162. UDI: (01)00884838115736(21)71403. Serial Numbers: 71403.
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.
FDA-determined cause: Under Investigation by firm
Action taken
Philips Medical notified consignees on about 04/14/2026 via letter. Consignees were made aware of the issue, affected units, and instructed to continue to use MDE as per established guidelines, manually update the scan protocol settings according to the directions provided to prevent the issue from occurring, and continue using the systems in accordance with their intended use. Consignees were also instructed to circulate the notice to all users for awareness, retain the Urgent Medical Device letter with affected systems until the software upgrade is installed and complete and return the provided response form.
Details
- Recall number
- Z-1955-2026
- Initiated
- April 14, 2026
- Posted by FDA
- April 27, 2026
- Product code
- LNH – System, Nuclear Magnetic Resonance Imaging
- Quantity
- 3 units
- Distribution
- Worldwide - 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…
- Recalling firm
- Philips North America, Cambridge, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1951-2026 Class II | Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1952-2026 Class II | Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF):…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1953-2026 Class II | Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1954-2026 Class II | Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1956-2026 Class II | Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1957-2026 Class II | Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1958-2026 Class II | Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1959-2026 Class II | Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2.…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1960-2026 Class II | Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2.…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1961-2026 Class II | Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2.…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1962-2026 Class II | Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2.…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1963-2026 Class II | Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2.…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1964-2026 Class II | Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1965-2026 Class II | Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF):…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1966-2026 Class II | Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF):…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1967-2026 Class II | Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1968-2026 Class II | Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number…The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |
| Z-1969-2026 Class II | Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.The potential for stiffness value errors when a specific range of image reconstruction parameters is used in… | 04/14/2026Open, Classified |