Device recall

Z-1699-2017: The Stryker Visum LED Surgical Lighting system is intended to illuminate the…

FDA device recall · Class II · Stryker Communications

Key facts

Recall number (Z-number) Z-1699-2017
Recall event 76633
Product 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…
Product code FSY
Recalling firm Stryker Communications
Recall class Class II
Status Terminated
Termination date Jan 8, 2018
510(k) numbers K060802
FEI number 3002975342

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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