Stryker Communications recalls EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following ca

Recalled May 29, 2019 · FDA recall Z-1388-2019 · Stryker Communications

Hazard

There is a potential the joint in the suspension of the device is insufficiently assembled. · FDA Class II

Units

3,176 devices

Sold at

Distribution was nationwide, including Puerto Rico. There was also government/military distribution. Foreign distribution was made to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, France, India, Japan, Korea, Mexico, Netherlands, Spain and United Kingdom.

Description

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

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.

Manufacturer(s)

Stryker Communications

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →