Class II

Medical Device Recall: Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.

Philips North America · January 3, 2024

Reason for Recall

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.

Distribution

Worldwide - US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

12 US; 45 OUS

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0952-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.