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Philips North America recalls Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
Recalled February 7, 2024 · FDA recall Z-0945-2024 · 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
119 US; 1,807 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
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
Manufacturer(s)
Philips North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →