Philips MRI Systems Recalled for Incorrect Cross-Reference Lines in Spine Imaging
Philips Medical Systems is recalling specific MRI systems due to a software defect that may cause cross-reference lines to be positioned incorrectly in spine clinical workflows.
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: The recall is classified as FDA Class II. The hazard is a software defect causing incorrect visual positioning of reference lines, which is a functional error rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity recall.
Plain-English summary
Philips Medical Systems, Inc. is recalling 317 units of Philips Ingenia, Intera, Achieva, and Multiva MR systems. The recall affects systems using R5.1i and R5.1.2 versions of the software. These devices are indicated for use as diagnostic devices to produce cross-sectional images, spectroscopic images, and/or spectra of the head, body, or extremities.
The recall is due to a software defect in spine clinical workflows. When MobiView fused images are used to display cross-reference lines, which help determine the position of slices, the lines may be positioned incorrectly. This could potentially affect the accuracy of the imaging data presented to the user.
The affected units were distributed worldwide, including in the United States and numerous international markets. Users of these specific MRI systems should contact Philips Medical Systems for further instructions on how to address the software issue.
The recalled product
- Product
- All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the…
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 317
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 (3)
- All Philips Ingenia
- Intera
- Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software
Distribution
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