Skytron Skyboom Series

• 2 recalls, same reason

  • Ongoing Z-1569-2020 FDA Class II ·initiated 5 Mar 2020
  • Terminated Z-1871-2016 FDA Class II ·initiated 28 Mar 2016

  Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.

• 2 recalls, same reason

  • Terminated Z-1496-06 FDA Unclassified (pre-2012) ·initiated 4 Aug 2005
  • Terminated Z-1497-06 FDA Unclassified (pre-2012) ·initiated 4 Aug 2005

  The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop.

510(k) Number

K950192 ↗

FDA Product Code

FQO

Device Class

Class I

Regulation

21 CFR Part 878.4960

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Stellar

  Class II

  FDA 510(k) K002463 Active Cleared 8 Nov 2000

• Skytron Elite 300 Surgery Table

  Class I

  FDA 510(k) K853479 Active Cleared 5 Sep 1985

• Skytron Universe Series Surgical Lights

  Class II

  FDA 510(k) K900211 Active Cleared 19 Mar 1990

• Skytron Model 610-2

  Class II

  FDA 510(k) K870045 Active Cleared 4 Feb 1987

• Skytron Model 130 Surgical Table

  Class I

  FDA 510(k) K873478 Active Cleared 24 Sep 1987

• Skytron Elite Surgical Tables

  Class II

  FDA 510(k) K811311 Active Cleared 2 Jun 1981

See all devices from Skytron, Div. the Kmw Group, Inc. →