The Recall Desk
HighFDA (Devices)·Z-1796-2025·Announced 2025-05-28

Medical Device: MRI Scanner Software Alignment Error in Image Review

Philips is recalling 2 Ingenia 1.5T S MRI scanners due to potential alignment errors in the MobiView image review application's cross-reference line functionality, which could affect diagnostic accuracy.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving potential diagnostic errors with no reported illnesses, injuries, or deaths. Per the rubric, medical devices with potential for harm but no reported injury are scored at most 3 (High).

Plain-English summary

Philips North America LLC is recalling 2 units of the Ingenia 1.5T S MRI scanner (Model 781347) due to potential alignment errors in image review software.

The MobiView application used to review images generated by these devices may produce alignment errors in the cross-reference line functionality. This could affect the accuracy of anatomical reference markers when reviewing diagnostic images.

The affected units are identified by Serial Numbers 81042 and 81072 and have been distributed to healthcare facilities in the United States and internationally.

Affected facilities should contact Philips North America LLC regarding this recall and available remediation options.

The recalled product

Product
Product Name: Ingenia 1.5T S; Model Number: 781347;
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Imaging
Hazard
  • alignment-error
  • diagnostic-error

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 (4)

  • Model Number: 781347
  • UDI-DI: 00884838068421
  • Serial Numbers: 81042
  • 81072

Distribution

Distributed nationwide across the United States.

Related recalls

Same category