Alm X'ten (X10) Surgical Light System

510(k) K040735

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

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 · Special	NumberK040735	Date21 May 2004Cleared	StatusActive

6 recalls · 1 ongoing · FDA

- Ongoing Z-0766-2024 FDA Class II initiated 8 Nov 2023
A potential for a light system to fall in the operating room.
- Terminated Z-1927-2018 FDA Class II initiated 16 Nov 2017
Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. The issue relates to cracking of the spring arms at the weld seams that has the potential to develop into breaks with heavy use and aging of the equipment.
- Terminated Z-1990-2015 FDA Class II initiated 29 May 2015
Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted above the surgical table.
3 recalls, same reason
- Terminated Z-0186-2010 FDA Unclassified (pre-2012) initiated 7 Oct 2009
- Terminated Z-0187-2010 FDA Unclassified (pre-2012) initiated 7 Oct 2009
- Terminated Z-0188-2010 FDA Unclassified (pre-2012) initiated 7 Oct 2009
Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm.

1 jurisdiction

United States — FDA 510(k) Active

510(k)