CLASS II ONGOING Device recall · Reported 4 Feb 2026 · FDA Enforcement Report
Evolution Upgrade 1.5T recalled by Philips North America
Philips North America is recalling Evolution Upgrade 1.5T, distributed nationwide in the US. The recall was initiated on 3 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1204-2026
- FDA event ID
- 98111
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Dec 2025
- FDA classified
- 29 Jan 2026
- Reported
- 4 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Dec 2025 | Recall initiated by company | |
| 29 Jan 2026 | Classified by FDA | +57 days |
| 4 Feb 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Product as listed by the FDA
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Where it was distributed
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.
Nationwide ArizonaCaliforniaColoradoIllinoisMassachusettsMaineMichiganMinnesotaMississippiNebraskaNew YorkOhioOregonPennsylvaniaSouth CarolinaTennesseeTexasVirginiaVermontWashington
Questions about this recall
Why was it recalled?
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Which lots are affected?
MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 782148. UDI-DI: 00884838108714. Serial Numbers: 70769, 70983. (2) Product Code (REF): 782116. UDI-DI: 00884838099722. Serial Number: 84741.
Where was it sold?
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
12 other products · FDA event 98111This product is part of a recall event; the main page for the event is SmartPath to dStream for 3.0T recalled by Philips North America.
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