Philips Ingenia MRI Scanner Body Coil Seal Adhesive May Fail
Philips is recalling Ingenia 1.5T CX MRI scanners because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients. Model numbers 781262 and 781261 are affected.
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 FDA Class II recall describes a medical device failure mode that creates sharp edges posing clear risk of patient injury including lacerations, tissue damage, and hair entanglement. It fits the High severity category as a risk-of-harm product.
Plain-English summary
Philips North America has issued a recall of the Ingenia 1.5T CX Magnetic Resonance Imaging (MRI) scanner, Model Numbers 781262 and 781261. These devices are medical imaging systems used in healthcare settings for diagnostic scans.
The recall was issued because the Quadrature Body Coil (QBC) seal adhesive may fail during use. If the seal becomes loose during scanning, it can create sharp edges that may contact patients, risking skin abrasions, bruises, lacerations, hair loss or entanglement, and tissue injury.
The recall affects all units of the stated models, with 146 units distributed outside the United States. The FDA has classified this as a Class II recall.
Healthcare facilities with these systems should consult the official FDA recall listing (Z-0950-2024) for further information.
The recalled product
- Product
- Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
- Manufacturer
- Philips North America
- Hazard
- sharp-edges
- laceration
- hair-entanglement
- tissue-injury
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)
- a. Model No. 781262
- UDI-DI 00884838068445. b. Model No. 781261
- UDI-DI 00884838068438. All units affected
Distribution
Distributed nationwide across the United States.
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