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Philips North America recalls SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
Recalled February 7, 2024 · FDA recall Z-0955-2024 · 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
37 US; 735 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
SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
Manufacturer(s)
Philips North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →