FDA-Device2016-02-17Class II
Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.
Philips Electronics North America Corporation
Hazard
Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced position).
Sold states
Worldwide Distribution. US states of TN and IN and the countries of Australia, Belgium, Egypt, France, Germany, Japan, Republic of Korea, Netherlands, and Saudi Arabia.
Affected count
2 subject to correction and removal
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0765-2016Don'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