[Recalled] Intera 1.5T Explorer/Nova Dual, Model Number: 781108; — The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges tha… | FDA 2025-03-24

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

This Class II recall concerns device products distributed in Netherlands and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

• Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 72 — Class II
• Intera 1.5T Master/Nova, Model Number: 781106; — Class II
• Azurion 7 M20. X-ray Image guided Therapy System. — Class II
• Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Mode — Class II
• Zenition 50, Model #718096 — Class II
• ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.