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
FDA Recall Z-1699-2017 · Posted 2017-03-10
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Recalling FirmStryker Communications
Recall StatusTerminated
Product CodeFSY
Date Initiated2017-02-28
Date Terminated2018-01-08
Product Quantity292 devices (in US)
Reason for Recall
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.
Firm Action
Stryker sent an Urgent Medical Device Correction letter dated March 3, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Distributors will notify customers via tracked Customer Notification Letter. A method of written communication will include a confirmation of delivery. For questions contact Stryker Technical Support at 800-243-5135 or [email protected]
Root Cause
Device Design
Distribution Pattern
Worldwide distribution - United States Nationwide - Australia, Canada, Great Britain, Japan, Netherlands and Puerto Rico
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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