FDA-Device2024-02-07Class II
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
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
119 US; 1,807 OUS
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0945-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief