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.
Reported: January 14, 2015 Initiated: November 26, 2014 #Z-0930-2015
Product Description
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.
Reason for Recall
STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
Details
- Recalling Firm
- Steris Corporation
- Units Affected
- 140 units
- Distribution
- Worldwide Distribution - USA including Alabama, Alaska, Arkansas, California, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Mississippi, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, and Virginia and Internationally to Canada, China, Greece, Indonesia, Republic of Korea, Romania, Russian Federation, Taiwan, and Viet Nam.
- Location
- Mentor, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Steris Corporation. Units affected: 140 units.
Why was this product recalled? ▼
STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 14, 2015. Severity: Moderate. Recall number: Z-0930-2015.
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