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Terminated

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.

FDA Recall Z-1850-2014 · Posted 2014-06-23

Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeFSY
Date Initiated2014-04-04
Date Terminated2014-10-15
Product Quantity68 units

Reason for Recall

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

Firm Action

On April 11, 2014 the firm sent Urgent Voluntary Field Correction Notices to their customers.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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