Philips Evolution upgrade 3: recall status

Notice names this product. Philips North America’s Philips Evolution upgrade 3 is named in FDA Class II recall Z-1955-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported 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. Identifying details: 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.. Units affected: 3 units. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Philips Evolution upgrade 3
Company / brand: Philips North America
Lot / serial / date codes: 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.
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.

Agency product description and boundaries

Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.

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If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand: Philips North America

Recalls naming this model

FDA Class II · Medical device · May 6, 2026

Philips Evolution upgrade 3 recall — Philips North America

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 …

Company / brand: Philips North America recalls

Affected product: Philips Evolution upgrade 3 recall status

Official ID Z-1955-2026 · Official record ↗

See all Philips North America recalls →

Verify with the official sources:

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FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.