Devices

Device Recall LED Surgical Light

Model / Serial
"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 Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution - United States Nationwide - Australia, Canada, Great Britain, Japan, Netherlands and Puerto Rico
Product Description
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/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), 0682001433 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P), 0682001434 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/5P), 0682001435 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/9P/5P) || Product Usage: || The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light
Manufacturer
Stryker Communications
1 Event
- Recall of Device Recall LED Surgical Light

Manufacturer

Stryker Communications

Manufacturer Address
Stryker Communications, 1410 Lakeside Pkwy Ste 100, Flower Mound TX 75028-4026
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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