Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony vLED Surgical Lighting System is a variable
FDA device recall Z-0930-2015 · posted 2015-01-07 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- Reason for recall
- STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
- Action taken
- 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.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- FST
- Quantity 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 Caro
- Date initiated
- 2014-11-26
- Date posted
- 2015-01-07
- Date terminated
- 2015-07-11
- Location
- Mentor, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HARMONY VLED SURGICAL LIGHTNING SYSTEM (K100395) | STERIS Corporation | 2010-03-17 |