Home / Recalls / Philips North America / Z-1964-2026

Z-1964-2026 Class II Ongoing

Recalled by Philips North America — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
May 6, 2026
Initiation Date
April 14, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25 untis

Product Description

Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.

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.

Distribution Pattern

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.

Code Information

1. Model Number (REF): 782120. UDI: (01)00884838104112(21)65019, (01)00884838104112(21)65004, (01)00884838104112(21)65028, (01)00884838104112(21)65031, (01)00884838104112(21)65039, (01)00884838104112(21)65056, (01)00884838104112(21)65066, (01)00884838104112(21)65065, (01)00884838104112(21)65038, (01)00884838104112(21)65005, (01)00884838104112(21)65043, (01)00884838104112(21)65049, (01)00884838104112(21)65051, (01)00884838104112(21)65060. Serial Numbers: 65019, 65004, 65028, 65031, 65039, 65056, 65066, 65065, 65038, 65005, 65043, 65049, 65051, 65060. 2. Model Number (REF): 782153. UDI: (01)00884838112858(21)68034, (01)00884838112858(21)68042, (01)00884838112858(21)68014, (01)00884838112858(21)68001, (01)00884838112858(21)68007, (01)00884838112858(21)68008, (01)00884838112858(21)68017, (01)00884838112858(21)68025, (01)00884838112858(21)68037, (01)00884838112858(21)68041, (01)00884838112858(21)68019. Serial Numbers: 68034, 68042, 68014, 68001, 68007, 68008, 68017, 68025, 68037, 68041, 68019.

Other recalls by Philips North America

  • Z-1953-2026 Class II — Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7812 (April 14, 2026)
  • Z-1962-2026 Class II — Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): (April 14, 2026)
  • Z-1952-2026 Class II — Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Num (April 14, 2026)
  • Z-1968-2026 Class II — Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model (April 14, 2026)
  • Z-1956-2026 Class II — Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7813 (April 14, 2026)
  • Z-1955-2026 Class II — Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number ( (April 14, 2026)
  • Z-1957-2026 Class II — Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 7 (April 14, 2026)
  • Z-1960-2026 Class II — Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF) (April 14, 2026)
  • Z-1966-2026 Class II — Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model N (April 14, 2026)
  • Z-1959-2026 Class II — Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 7 (April 14, 2026)