FDAClass IIApril 5, 2017

The Stryker Visum¿ LED Surgical Lighting system is recall

The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light.…

Why was The Stryker Visum¿ LED Surgical Lighting system is recalled?

The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall.

What should I do if I have this product?

Review the official FDA enforcement record for current 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: 100000000098399 100000000099187 100000000099193 100000000093937 100000000094391 100000000093936 100000000087555 100000000091032 100000000093938 100000000093928 100000000093939 100000000098397 100000000092672 100000000093927 100000000106675 100000000106685 100000000109560 100000000109569 100000000109570 100000000086360 100000000089194 100000000091766 100000000091778 100000000098401 100000000099325 100000000103228 100000000090520 100000000102434 100000000102439 100000000103111 100000000088303 100000000089467 100000000094993 100000000095927 100000000101580 100000000092699 100000000101590 100000000101591 100000000103686 100000000109291 100000000097048 100000000112633 100000000087549 100000000094982 100000000091762 100000000112607 100000000112609 100000000091531 100000000106681 100000000106682 100000000106684 100000000106159 100000000091728 100000000103271 100000000090522 100000000099356 100000000089970 100000000090530

Product
The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light.…
Recalling firm
Stryker Communications
Quantity
292 devices (in US)
Distribution
Worldwide distribution - United States Nationwide - Australia, Canada, Great Britain, Japan, Netherlands and Puerto Rico
Recall date
April 5, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls