Recall Z-0952-2024— Philips North America

Name: FDA recall Z-0952-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-03

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2024-01-03. It names one FDA 510(k) clearance: K193215. Product: Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.. Reason: 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..

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2024-01-03
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K193215 — Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.·cleared 2020-04-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.