Sola 700, Sola 500, Sola 300

• • Terminated Z-1850-2014 FDA Class II ·initiated 4 Apr 2014 ·on shared 510(k) K010724

  Potential for the welded seam in affected monitor spring arms to crack and/or break.

• • Terminated Z-0414-2010 FDA Unclassified (pre-2012) ·initiated 11 Sep 2009

  Drger Medical AG & Co., KGaA informed STERIS Corporation that they received (4) reported international cases where a welded seam at the joint of the spring-loaded arm of the Drger SOLA 500/700 surgical light broke as a result of a crack that had slowly developed over time. The STERIS Harmony LL 500/700 surgical light is a Private Label version of the Drger SOLA 500/700 surgical light.

• • Terminated Z-2212-2009 FDA Unclassified (pre-2012) ·initiated 26 Aug 2009

  welded seam may fail

• 2 recalls, same reason

  • Terminated Z-0359-04 FDA Unclassified (pre-2012) ·initiated 9 Jan 2004
  • Terminated Z-0358-04 FDA Unclassified (pre-2012) ·initiated 9 Jan 2004

  adjustment screw may break due to material fatigue

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K010724 ↗

FDA Product Code

FTD

Device Class

Class II

Regulation

21 CFR Part 878.4580

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Caleo

  Class II

  FDA 510(k) K003067 Active Cleared 13 Dec 2000

• Oxylog 1000, Model 2M86840

  Class II

  FDA 510(k) K010793 Active Cleared 20 Dec 2001

• Non-Invasive Ventilation NIV Option, Model 84 14 474

  Class II

  FDA 510(k) K010093 Active Cleared 14 Jun 2001

• Option Niv, Model 8414115, Upgrade Kit Niv, Model 8414072

  Class II

  FDA 510(k) K023289 Active Cleared 15 Jan 2003

• Drager Sola Series, Models 1000/700/500/300

  Class II

  FDA 510(k) K984611 Active Cleared 29 Mar 1999

• Ventview, Model 8414095

  Class II

  FDA 510(k) K012177 Active Cleared 4 Sep 2001

See all devices from Drager Medizintechnik GmbH →