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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- Stryker Communications
- Affected units
- 292
Distribution
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