ClearanceBrief
Recall Z-1388-2019 ยท FSY Light, Surgical, Ceiling Mounted

Stryker Communications

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 Ax

DateNov 13, 2018
StatusOpen, Classified
ReasonThere is a potential the joint in the suspension of the device is insufficiently assembled.
Root causeEmployee error
ActionThe recalling firm issued letters dated 11/13/2018 via FedEx informing to customers. The letter identified the affected product problem and actions to be taken. The customer is asked to disseminate the information within their organization. A response form was enclosed to indicate the customer has read and understands the instructions in the letter. The form was to be returned to the recalling firm via email. Customer was notified that a Stryker representative will begin visiting customer facilities in November to inspect their equipment. For questions contact " Stryker Technical Support
Quantity3,176 devices
DistributionDistribution 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K060802VISUM LED SURGICAL LIGHTING SYSTEM
Stryker Communications Corp., Apr 7, 2006