Philips Ingenia 1.5T CX MRI System Alignment Error Recall
Philips MRI systems may experience alignment errors in the MobiView application's cross-reference line functionality when reviewing images. Nine units have been distributed worldwide.
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 Class II recall involves a diagnostic medical imaging device where alignment errors could affect the accuracy of image interpretation. No injuries or illnesses have been reported, but the hazard presents a risk of potential diagnostic harm, meeting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Philips North America LLC is recalling certain Ingenia 1.5T CX MRI systems (Model 781262) due to potential alignment errors in the MobiView application's cross-reference line functionality. When reviewing MRI images, the cross-reference lines may not align correctly, which could affect image analysis.
Nine units of this MRI system have been distributed worldwide, including to the United States and 50+ other countries and territories. The affected serial numbers are: 77059, 77120, 77158, 77161, 77178, 77182, 77191, 77193, and 77203. No injuries or illnesses have been reported in connection with this issue.
The recalled product
- Product
- Product Name: Ingenia 1.5T CX; Model Number: 781262;
- Manufacturer
- Philips North America Llc
- 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 (11)
- Model Number: 781262
- UDI-DI: 00884838068445
- Serial Numbers: 77059
- 77120
- 77158
- 77161
- 77178
- 77182
- 77191
- 77193
- 77203
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03