Recall Z-0930-2015— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2014-11-26, terminated 2015-07-11. It names one FDA 510(k) clearance: K100395. Product: 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: STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-26
- Terminated
- 2015-07-11
- Firm location
- Mentor, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.