Iled

510(k) K061317

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK061317	Date22 Jun 2006Cleared	StatusActive

7 recalls · FDA

- Completed Z-0563-2016 FDA Class II initiated 2 Nov 2015
The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.
4 recalls, same reason
- Terminated Z-2354-2015 FDA Class II initiated 27 Jul 2015
- Terminated Z-2353-2015 FDA Class II initiated 27 Jul 2015
- Terminated Z-2356-2015 FDA Class II initiated 27 Jul 2015
- Terminated Z-2357-2015 FDA Class II initiated 27 Jul 2015
Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
- Terminated Z-2311-2012 FDA Class II initiated 29 May 2012
Cracks can arise on the welded seam on the rear joint.
- Terminated Z-1122-2009 FDA Unclassified (pre-2012) initiated 27 Feb 2009
Cracks may form around the screw connections of the cover plates causing brittleness, which may lead to fragments breaking off and falling into the operating area.

1 jurisdiction

United States — FDA 510(k) Active

510(k)