Philips MR 7700 Device Recall Announced

Source: FDA · United States

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Philips North America is recalling 25 units of its MR 7700 with MR Elastography due to potential errors in stiffness value measurements.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 14, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Philips North America has initiated a voluntary recall of certain medical devices due to the potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, which could lead to incorrect reconstruction voxel size settings in the default MRE scan protocol.

Which Products Are Affected

The affected products are Philips MR 7700 with MR Elastography, specifically Model Number 782120 and Model Number 782153. For Model 782120, the UDI codes include (01)00884838104112 with various serial numbers: 65019, 65004, 65028, 65031, 65039, 65056, 65066, 65065, 65038, 65005, 65043, 65049, 65051, 65060. For Model 782153, the UDI codes include (01)00884838112858 with serial numbers: 68034, 68042, 68014, 68001, 68007, 68008, 68017, 68025, 68037, 68041, 68019. A total of 25 units are affected, distributed US nationwide and in various international countries including Argentina, Australia, and others.

What You Should Do

Consumers and users should contact the recalling firm, Philips North America, as they were notified via letter, for further instructions on the recall.

Why This Matters

This recall addresses potential inaccuracies in medical imaging devices, which could impact diagnostic procedures; it affects 25 units distributed widely, highlighting the importance of device accuracy in healthcare.

Source

This information is from the FDA recall database, recall number Z-1964-2026, attributed to the U.S. Food and Drug Administration (FDA).

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Philips North America is recalling 25 units of its MR 7700 with MR Elastography due to potential errors in stiffness value measurements.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.