Reported May 29, 2019 · Ongoing

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

Stryker Communications

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Communications · 571 Silveron Blvd · Flower Mound, TX · 75028

EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System
with the following catalog numbers0682001286, 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 UsageThe lighting system is intended to illuminate the operative site during surgical procedures with high intensity light

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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