Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights ar
FDA device recall Z-2354-2015 · posted 2015-08-07 · Terminated
Recall details
- Recalling firm
- Trumpf Medical Systems, Inc.
- Reason for recall
- Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
- Action taken
- Consignees were notified by letter on/about 7/27/2015.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FSY
- Quantity affected
- 9,287 units total
- Distribution
- Worldwide Distribution-US (nationwide) including Puerto Rico, and the countries of Angola, Antilles, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Belgium, Bulgaria, Bahrain, Bras
- Date initiated
- 2015-07-27
- Date posted
- 2015-08-07
- Date terminated
- 2017-05-03
- 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 |
|---|---|---|
| ILED (K061317) | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2006-06-22 |