# K061317: ILED

- Pathway: 510(k) (Traditional)
- Applicant: Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg
- Decided: Jun 22, 2006 after 42 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K965130 (1997). 2 ancestors in all.
16 later devices descend from it; 7 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024132: Chromophare X 65, Berchtold Holding GmbH (2003) Summary page 2.

## Most influential descendants
- K072072: Harmony Led-1 Surgical Lighting System (2007), 10 descendants of its own
- K093009: Mach Led SC (2010), 4 descendants of its own
- K093010: Mach Led MC (2010), 2 descendants of its own
- K132307: Vida Led Surgical Lighting System (2013), 1 descendant of its own
- K100388: 21ST Century Centurion Exceled and System Two Led Lighting Systems (2010), 1 descendant of its own

## Recalls of this device
- Nov 2, 2015 · Class II · Z-0563-2016: 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
- Jul 27, 2015 · Class II · Z-2353-2015: Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
- Jul 27, 2015 · Class II · Z-2354-2015: Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
- Jul 27, 2015 · Class II · Z-2356-2015: Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
- Jul 27, 2015 · Class II · Z-2357-2015: Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
- May 29, 2012 · Class II · Z-2311-2012: Cracks can arise on the welded seam on the rear joint.
- Feb 27, 2009 · Not classified · Z-1122-2009: 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.

## Indications for use
The surgical light iLED is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow fee, "cold" light,

Source page: https://510kreport.com/device/K061317
Methodology: https://510kreport.com/methodology