Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1850-2014

April 04, 2014

Class II

Product summary

Firm
Steris Corporation
Event
Event 68128
Status
Terminated
Classification
Class II
Quantity
68 units
Official record key
device-enforcement:Z-1850-2014

Official wording

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

Code information: Model #: YG19051, Serial #'s: 01108340587, 01117338881, 011106337516, 011106337525, 011106337527, 011106337534, 011106337535, 011106337538, 011106337539, 011106337541, 011106337626, 011107338878, 011107338882, 011107338883, 011108340587, 011108340600, 0111073388883 & 011108340600A. Model #: YG19262, Serial #: ART00001 - ART00010, CADS0001 - CADS0015, CBX0001 - CBX0010 & CXSG0008 - CXSG0022.

Distribution pattern: Distribution to US (states: MA, NY, OH, PA & TX) and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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