Stryker Communications recalls The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures

Recalled April 5, 2017 · FDA recall Z-1699-2017 · Stryker Communications

Hazard

The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall. · FDA Class II

Units

292 devices (in US)

Sold at

Worldwide distribution - United States Nationwide - Australia, Canada, Great Britain, Japan, Netherlands and Puerto Rico

Description

The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall.

Product

The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 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), 0682001433 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P), 0682001434 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/5P), 0682001435 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/9P/5P) Product Usage: The Stryker Visum LED Surgical 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 →