Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an o
FDA device recall Z-0077-2013 · posted 2012-10-18 · Terminated
Recall details
- Recalling firm
- Trumpf Medical Systems, Inc.
- Reason for recall
- Incidents regarding fractures of the front joint of the spring arm have been reported.
- Action taken
- Trumpf sent an "URGENT RECALL NOTICE" dated September 19, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Confirmation of Receipt Form was attached for customers to complete and return. Contact the firm at 888-474-9359 for questions regarding this notice.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FSY
- Quantity affected
- 275 units
- Distribution
- Nationwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, IL, KS, MA, MI, MO, NC, NJ, NY, OH, SC, TX, UT, VT and WI.
- Date initiated
- 2012-09-19
- Date posted
- 2012-10-18
- Date terminated
- 2014-01-21
- Location
- Charleston, SC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 (K011693) | Trumpf Medical Systems, Inc. | 2001-06-13 |