MRI diagnostic device tabletop may not move completely in manual mode
Philips Ingenia 1.5T MRI systems may have a mechanical defect where the tabletop fails to move fully in and out during manual operation, potentially delaying patient evacuation and treatment.
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 a mechanical defect in a diagnostic device that poses a risk of patient evacuation delay from the MRI bore. No injuries or illnesses have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a High classification.
Plain-English summary
Philips North America LLC is recalling certain Ingenia 1.5T magnetic resonance (MRI) diagnostic imaging systems due to a potential malfunction of the tabletop movement mechanism in manual mode.
The affected systems (Models 781341 and 781396) may fail to move the tabletop completely in or out when operating in manual mode. This could result in delays in patient evacuation from the MRI bore and delays in treatment delivery.
The systems have been distributed worldwide, including throughout the United States. Affected units are identified by specific serial numbers and unique device identifiers (UDI) listed in the FDA recall database.
Patients and healthcare facilities using these systems should contact Philips for guidance on the malfunction, available repairs, or workarounds. No injuries have been reported to the FDA at this time.
The recalled product
- Product
- Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781
- Manufacturer
- Philips North America Llc
- Hazard
- device-malfunction
- evacuation-delay
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03