FDAClass IIMay 29, 2019

EDS Light Suspension recall

EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS…

Why was EDS Light Suspension recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial numbers 100000000065406 to 100000000106685.

Product
EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS…
Recalling firm
Stryker Communications
Quantity
3,176 devices
Distribution
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.
Recall date
May 29, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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