Z-1954-2026Class II
Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number...
Philips North America LLC / initiated 2026-04-14 / Open, Classified / root cause: software
Philips North America began a recall of Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as software.
Recall record
- Recall number
- Z-1954-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Philips North America LLC
- Product
- Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.
- Product code
- LNH System, Nuclear Magnetic Resonance Imaging
- 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.
- Root cause tag
- software
- FDA root cause
- Under Investigation by firm
- Action
- 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.
- Quantity in commerce
- 8 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, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.
- Product codes and lots
- 1. Model Number (REF): 782116. UDI: (01)00884838099722(21)41527, (01)00884838099722(21)70949, (01)00884838099722(21)84741. Serial Numbers: 41527, 70949, 84741. 2. Model Number (REF): 782148. UDI: (01)00884838108714(21)84560, (01)00884838108714(21)41277, (01)00884838108714(21)70769, (01)00884838108714(21)70983. Serial Numbers: 84560, 41277, 70769, 70983. 3. Model Number (REF): 782166. UDI: (01)00884838115774(21)70042. Serial Numbers: 70042.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1951-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1952-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1953-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1954-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1955-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1956-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1957-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1958-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1959-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1960-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1961-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1962-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1963-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1964-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1965-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1966-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1967-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1968-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1969-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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