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Philips North America recalls Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
Recalled February 7, 2024 · FDA recall Z-0952-2024 · Philips North America
Hazard
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. · FDA Class II
Units
12 US; 45 OUS
Sold at
Worldwide - US Nationwide distribution.
Description
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.
Product
Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
Manufacturer(s)
Philips North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →