Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Intera 1.5T R11 Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Due to The Quadrature Body Coil (QBC) seal adhesive may...

Date: March 24, 2025
Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. directly.

Affected Products

Intera 1.5T R11, Model Number: 781170;

Quantity: 23 units (10 US, 13 OUS)

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 154 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report