Home / Recalls / Philips North America / Z-1962-2026

Z-1962-2026 Class II Ongoing

Recalled by Philips North America — Cambridge, MA

FDA device recall Z-1962-2026 was initiated by Philips North America on April 14, 2026 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 6 units.

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
6 units

Product Description

Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.

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): 781357. UDI: (01)00884838088108(21)46002. Serial Numbers: 46002. 2. Model Number (REF): 782106. UDI: (01)00884838098329(21)46243, (01)00884838098329(21)46292, (01)00884838098329(21)46317. Serial Numbers: 46243, 46292, 46317. 3. Model Number (REF): 782137. UDI: (01)00884838108615(21)64034, (01)00884838108615(21)64045. Serial Numbers: 64034, 64045.

Other recalls by Philips North America

  • Z-2579-2026 Class II — Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the follo (June 5, 2026)
  • Z-2523-2026 Class II — Philips Avalon Fetal Monitor, FM 30 Part numberM2703A (May 26, 2026)
  • Z-2522-2026 Class II — Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A (May 26, 2026)
  • Z-2354-2026 Class II — DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. (May 1, 2026)
  • Z-1957-2026 Class II — Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 7 (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-1964-2026 Class II — Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. (April 14, 2026)
  • Z-1955-2026 Class II — Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number ( (April 14, 2026)
  • Z-1963-2026 Class II — Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): (April 14, 2026)
  • Z-1961-2026 Class II — Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF) (April 14, 2026)

FDA data resources