CLASS II ONGOING Device recall · Reported 4 Feb 2026 · FDA Enforcement Report

Upgrade to MR recalled by Philips North America

Philips North America is recalling Upgrade to MR 7700, 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

Lot, batch or date codesMR systems with SW version R11.1 and R12.1. Product Code (REF): 782130. UDI-DI: 00884838104402. Serial Numbers: 42030, 85644, 42163, 42151, 45236, 85643.

Quantity recalled6 units

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-1214-2026
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

Upgrade to MR 7700. Product Code (REF): 782130. 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 Arizona California Colorado Illinois Massachusetts Maine Michigan Minnesota Mississippi Nebraska New York Ohio Oregon Pennsylvania South Carolina Tennessee Texas Virginia Vermont Washington

Questions about this recall

Is Upgrade to MR 7700 recalled?

Yes. Philips North America recalled Upgrade to MR 7700 on 3 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-1214-2026.

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. Product Code (REF): 782130. UDI-DI: 00884838104402. Serial Numbers: 42030, 85644, 42163, 42151, 45236, 85643.

Where was it sold?

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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