FDA-Device2020-05-13Class II
Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
Philips North America, LLC
Hazard
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
Sold states
Worldwide distribution including one unit distributed to Iowa.
Affected count
2
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1923-2020Don'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