Reported Jan 14, 2015 · Terminated

Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a…

Steris Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834

Is this the product you have?

  • Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff.
Lot codes and dates
  • The following item
  • numbers are included in this recall
    • B136824175
    • B136824176
    • B136824177
    • B136824178
    • B136824179
    • B136824427
    • B136824430
    • B136824431
    • LK01N
    • and LK05N
Amount recalled
140 units

Where it was sold

Why it was recalled

STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 11, 2015 · Data as of Sep 19, 4:52 PM UTC

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