Recall Z-0930-2015 ยท FST Light, Surgical, Fiberoptic
Steris Corporation
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.
| Date | Jan 7, 2015 (initiated Nov 26, 2014) |
| Status | Terminated |
| Reason | STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently. |
| Root cause | Software Design Change |
| Action | STERIS sent an Urgent Voluntary Field Correctionn Notice to all affected consignees via FedEx. The Consignee Notification mailing was initiated the week of December 15, 2014. Customers were instructed that their local STERIS representative would contact their facility to arrange for the installation of updated software. Customers with questions were instructed to call 1-800-548-4873. For questions regarding this recall call 440-392-7231. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100395 | HARMONY VLED SURGICAL LIGHTNING SYSTEM STERIS Corporation, Mar 17, 2010 |