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Ingenia recallZ-1216-2026 · Philips North America · initiated Dec 3, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips North America or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

FDA root cause category: Software design

What the company is doing

Philips began notification of consignees on about 12/03/2025 via mailed Urgent Medical Device Correction letter, with a corrected notification sent on about 12/18/2025. Consignees were instructed to identify if any affected units were on hand, that the systems could continue to be use in accordance with their intended use. They were asked to provide the notification to all users of the device for awareness, maintain the Urgent Medical Device Correction letter with affected systems until the software upgrade is installed, and complete and return the provided response form. A Philips representative will contact each consignee to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issues beginning in January 2026 (reference FCO78100585, FCO78100620).

Recall details

Recall number
Z-1216-2026
Status
Open, Classified
Initiated by the company
Dec 3, 2025
Posted by the FDA
Jan 29, 2026
Recalling firm
Philips North America
Quantity
3 units
Product code
LNH
FDA submissions
K183063
Distribution
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.

Product description

SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.

Code information (models, lots, serial numbers)

MR systems with SW version R11.1 and R12.1. Product Code (REF): 781270. UDI-DI: 00884838095083. Serial Numbers: 24066, 38113, 17356.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 98111).

Sources and updates

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