Recall Z-1850-2014— Steris Corporation

Name: FDA recall Z-1850-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-04

Class II · Terminated

Class II FDA medical device recall by Steris Corporation, initiated 2014-04-04, terminated 2014-10-15. It names one FDA 510(k) clearance: K010724. Product: Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262.. Reason: Potential for the welded seam in affected monitor spring arms to crack and/or break..

Recalling firm: Steris Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-04-04
Terminated: 2014-10-15
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K010724 — SOLA 700,SOLA 500, SOLA 300Drager Medizintechnik GmbH·cleared 2001-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.