Device recall

Z-0524-2007: Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs…

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

Key facts

Recall number (Z-number) Z-0524-2007
Recall event 37120
Product Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.
Product code FTD
Recalling firm Skytron, Div. The KMW Group, Inc
Recall class Class II
Status Terminated
Termination date Nov 18, 2009
510(k) numbers K915285
FEI number 1825014

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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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