The Recall Desk
SevereFDA (Devices)·Z-1699-2017·Announced 2017-04-05

Stryker Visum LED Surgical Lighting System Recalled for Mounting Defect

Stryker is recalling 292 Visum LED Surgical Lighting systems because missing screws and user overloading may cause the equipment to fall.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (falling equipment) that poses a risk of significant injury or property damage, meeting the criteria for a Severe rating.

Plain-English summary

Stryker Communications is recalling 292 units of the Stryker Visum LED Surgical Lighting system. The recall involves specific part numbers for the EDS Light Suspension, Central Axis, including 0682001432, 0682001286, 0682001298, 0682001299, 0682001300, 0682001433, 0682001434, and 0682001435. The devices are intended to illuminate the operative site during surgical procedures with high-intensity light.

The recall is due to a potential hazard where missing screws combined with overloading by the end user can result in insufficient mount force. This condition may cause the equipment to fall. The agency has classified this as a Class II recall.

The affected devices were distributed worldwide, including in the United States, Australia, Canada, Great Britain, Japan, the Netherlands, and Puerto Rico. A list of specific serial numbers for the affected units is available in the source documentation. Users should check their equipment against the provided serial numbers and contact Stryker Communications for further instructions.

The recalled product

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/
Manufacturer
Stryker Communications
Category
Medical Device — Surgical Lighting
Hazard
Affected units
292

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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