Harmony¿ vLED Surgical Lighting System recall
Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a variable pattern, variable intensity…
Why was Harmony¿ vLED Surgical Lighting System recalled?
STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
The following item numbers are included in this recall: B136824175, B136824176, B136824177, B136824178, B136824179, B136824427, B136824430, B136824431, LK01N, and LK05N.
- Product
- Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a variable pattern, variable intensity…
- Recalling firm
- Steris Corporation
- Quantity
- 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.
- Recall date
- January 14, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)