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
B136824175B136824176B136824177B136824178B136824179B136824427B136824430B136824431LK01Nand 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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