Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1964-2026·Announced 2026-05-06

Philips MR 7700 MR Elastography device stiffness value error recall

Philips is recalling certain MR 7700 devices with MR Elastography due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause voxel size settings to display incorrectly.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The source text indicates a potential for measurement or display errors under specific parameter conditions, but does not report any actual injuries, hospitalizations, or deaths. No illnesses or adverse health outcomes are stated.

Plain-English summary

Philips North America is recalling certain Philips MR 7700 devices equipped with MR Elastography (MRE). The affected units are Model Number 782120 and Model Number 782153, distributed worldwide including throughout the United States.

The recall is prompted by a potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. This combination can cause the reconstruction voxel size settings in the default MRE scan protocol to display too small.

Users of affected devices should contact Philips North America for instructions on how to address this issue. Specific guidance on remediation steps should be obtained from the manufacturer.

The recalled product

Product: Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
Manufacturer: Philips North America
Category: Medical Device — MRI / Imaging Equipment
Hazard: measurement-error
incorrect-display
Affected units: 25

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

1. Model Number (REF): 782120. UDI: (01)00884838104112(21)65019
(01)00884838104112(21)65004
(01)00884838104112(21)65028
(01)00884838104112(21)65031
(01)00884838104112(21)65039
(01)00884838104112(21)65056
(01)00884838104112(21)65066
(01)00884838104112(21)65065
(01)00884838104112(21)65038
(01)00884838104112(21)65005
(01)00884838104112(21)65043
(01)00884838104112(21)65049
(01)00884838104112(21)65051
(01)00884838104112(21)65060. Serial Numbers: 65019
65004
65028
65031
65039
65056
65066

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

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Same hazard · measurement error