Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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 Axis 9P/FP; 0682001433, EDS Light Suspension, Central Axis, 9P; 0682001434, EDS Light Suspension, Central Axis, 9P/5P; and 0682001435, EDS Light Suspension, Central Axis, FP/9P/5P. Product Usage: The lighting system is intended to illuminate the operative site during surgical procedures with high intensity light.

FDA Recall Z-1388-2019 · Posted None

Recalling FirmStryker Communications
Recall StatusOpen, Classified
Product CodeFSY
Date Initiated2018-11-13
Product Quantity3,176 devices

Reason for Recall

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

Firm Action

The 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 at (800) 243-5135 or [email protected]

Root Cause

Employee error

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060802VISUM LED SURGICAL LIGHTING SYSTEMStryker Communications Corp. · 2006-04-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑