Recall Z-2355-2015 ยท FSY Light, Surgical, Ceiling Mounted
Trumpf Medical Systems, Inc.
Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
| Date | Aug 7, 2015 (initiated Jul 27, 2015) |
| Status | Terminated |
| Reason | Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. |
| Root cause | Process control |
| Action | Consignees were notified by letter on/about 7/27/2015. |
| Quantity | 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, Brasilia, Belarus, Canada, Switzerland, Chile, China, Columbia, Cyprus, Czech Republic, Germany, Denmar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011693 | TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 Trumpf Medical Systems, Inc., Jun 13, 2001 |