medical Class II Updated 2019-05-29

Stryker Communications recalls EDS Light Suspension, Central Axis, a component of the Stryk

Recalled Product

EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P; 0682001300, EDS Light Suspension, Central Axis, FP/5P/5P; 0682001432, EDS Light Suspension, Central Axis 9P/FP; 0682001433, EDS Light Suspension, Central Axis, 9P; 0682001434, EDS Light Suspension, Central Axis, 9P/5P; and 0682001435, EDS Light Suspension, Central Axis, FP/9P/5P. Product Usage: The lighting system is intended to illuminate the operative site during surgical procedures with high intensity light.


Hazard / Issue

There is a potential the joint in the suspension of the device is insufficiently assembled.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial numbers 100000000065406 to 100000000106685.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →