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Recall Observatory FDA recall evidence

Device 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.

Z-1388-2019

November 13, 2018

Class II

Product summary

Firm
Stryker Communications
Event
Event 82476
Status
Ongoing
Classification
Class II
Quantity
3,176 devices
Official record key
device-enforcement:Z-1388-2019

Official wording

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

Code information: Serial numbers 100000000065406 to 100000000106685.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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