Product Wiki · Recalls · U.S. FDA — Device Enforcement

Intera 1.5T Master/Nova, Model Number: 781106; — recall Z-1776-2025

U.S. FDA — Device Enforcement · Netherlands · 2025-03-24 · Class II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1776-2025
Date of alert
2025-03-24
Country / jurisdiction
Netherlands
Risk level
Class II
Notice type
recall
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican R
Reported risk: 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.
What to do

Check whether your product matches this notice (name, batch, dates). If it does, stop using it and follow the instructions in the official notice — refund, return, repair or disposal are set by the issuing authority and the business, and they differ per recall. Official notice from U.S. FDA — Device Enforcement →

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.