510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1850-2014Class II

Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting...

STERIS Corporation / initiated 2014-04-04 / Terminated / root cause: design

Steris Corporation began a recall of Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051... on . FDA classified it as Class II and gives the reason as "Potential for the welded seam in affected monitor spring arms to crack and/or break". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1850-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
STERIS Corporation
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.
Product code
FSY Light, Surgical, Ceiling Mounted
Reason for recall
Potential for the welded seam in affected monitor spring arms to crack and/or break.
Root cause tag
design
FDA root cause
Device Design
Action
On April 11, 2014 the firm sent Urgent Voluntary Field Correction Notices to their customers.
Quantity in commerce
68 units
Distribution
Distribution to US (states: MA, NY, OH, PA & TX) and Canada.
Product codes and lots
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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1850-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1850-2014Class IITerminatedVoluntary: Firm initiated