FDA-Device2024-02-07Class II
Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
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.
Sold states
Worldwide - US Nationwide distribution.
Affected count
4 US; 17 OUS
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0953-2024Don't want to check this manually?
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