Intera 1 recalled over laceration hazard

Recall date

March 24, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 1.5T, Model Numbers: 781195 and 781295;

Recall number

Z-1774-2025

FDA classification

Class II

Brand / firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Sold / distributed

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…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Intera 1.5T, Model Numbers: 781195 and 781295;