Device recall

Z-0109-2021: SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage…

FDA device recall · Class II · Skytron, Div. The KMW Group, Inc

Key facts

Recall number (Z-number) Z-0109-2021
Recall event 86439
Product SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit for use in the operating room.
Product code LMD
Recalling firm Skytron, Div. The KMW Group, Inc
Recall class Class II
Status Terminated
Termination date Jun 1, 2021
FEI number 1825014

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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