Recall of Philips MR 7700 Upgrade

Source: FDA · United States

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Philips North America is recalling 15 units of the Philips Upgrade to MR 7700 with MR Elastography due to potential errors in stiffness values from specific image reconstruction parameters.

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 is recalling the product due to 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.

Which Products Are Affected

The affected product is the Philips Upgrade to MR 7700 with MR Elastography (MRE), with Model Number (REF) 782130. A total of 15 units are involved, distributed worldwide including US Nationwide and countries such as Argentina, Australia, and others. The serial numbers include 45052, 42030, 42151, 71279, 71565, 42104, 42163, 42376, 45179, 45236, 45263, 71532, 85394, 85643, and 85644. The Universal Device Identifier (UDI) codes are (01)00884838104402(21)45052, (01)00884838104402(21)42030, and others as listed.

What You Should Do

Affected users should follow the instructions in the initial notification letter from Philips North America, as this is a voluntary firm-initiated recall.

Why This Matters

This recall addresses potential inaccuracies in medical imaging devices, which could impact diagnostic results and patient care; it involves 15 units distributed across the US and internationally, highlighting the need for precise medical equipment.

Source

Attribution: FDA Recall Number Z-1969-2026. For more information, visit the FDA website at https://www.fda.gov.

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 15 units of the Philips Upgrade to MR 7700 with MR Elastography due to potential errors in stiffness values from specific image reconstruction parameters.
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.