Philips Intera MRI Coil Seal Failure May Cause Patient Injury
The Quadrature Body Coil seal adhesive on Philips Intera 1.5T MRI systems may fail, creating sharp edges that could injure patients during scanning, causing abrasions, lacerations, or tissue damage.
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 with no reported illnesses or injuries documented in the source. The hazard involves potential patient contact with sharp edges capable of causing skin abrasions, lacerations, and tissue injury, meeting the rubric criterion for 'High': a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling approximately 121 units of the Intera 1.5T Power/Pulsar MRI system (Model 781105) due to potential failure of the Quadrature Body Coil (QBC) seal adhesive.
The adhesive securing the QBC seal may fail, creating sharp edges that can contact patients during scanning. If the seal becomes loose, patients may experience skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.
The affected units are distributed nationwide in the United States (51 units) and internationally across approximately 80 countries. All units with Model 781105 and any serial number are potentially at risk.
Healthcare facilities with this equipment should contact Philips Medical Systems Nederland B.V. for information about corrective actions and to discuss appropriate remediation.
The recalled product
- Product
- Intera 1.5T Power/Pulsar, Model Number: 781105;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — MRI System
- Hazard
- sharp-edges
- laceration-risk
- tissue-injury
- entanglement-risk
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)
- Model Number (REF): 781105
- UDI-DI: N/A
- All serial numbers.
Distribution
Distributed nationwide across the United States.
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