Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
All Philips Ingenia Recalled by Philips Medical Systems, Inc. Due to In spine clinical workflows, cross reference lines may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems, Inc. directly.
Affected Products
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 head, body, or extremities.
Quantity: 317
Why Was This Recalled?
In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases, where MobiView fused Images are used to show the cross reference lines, the cross reference lines may be positioned incorrectly.
Where Was This Sold?
This product was distributed to 22 states: AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, KY, MA, MI, NY, OH, OR, PA, SC, TX, VT, VA, WA
About Philips Medical Systems, Inc.
Philips Medical Systems, Inc. has 65 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report