FDA Medical Device Recalls (openFDA)
Trumpf Medical Systems, Inc.: Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
- Recall number
- Z-0563-2016
- Recalling firm
- Trumpf Medical Systems, Inc.
- Product
- Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
- Status
- Completed
- Initiated
- 2015-11-02
- Posted
- not on file
- Terminated
- not on file
- Reason
- The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.
- Root cause
- Other
- Action
- TRUMPF sent an " Urgent Field Safety Information" letter dated December 8, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by the customer: 1. Perform an inspection of the lighting systems (see Appendix 1 for instructions). If any of the symptoms listed below are observed, immediately remove the light from operation and contact your Trumpf Medical Service Representative or designee. Signs that indicate a possible fall of the spring arm: The movement of the light and spring arm is difficult for the user, The lights have stopped being operational, and/or A gap is noticed between the spring arm and the central axis (see the attached Appendix 1 for an example). 2. Follow the User Manual: No unauthorized servicing of the spring arm is permitted. Snap rings are one use only and replacements must be purchased from your authorized Trumpf Medical partner. If you have any questions concerning this request or the procedure as outlined, please contact TRUMPF Medical Systems, Inc. at 888-474-9359
- Quantity
- 20,713
- Distribution
- USA (nationwide) Distribution to the states of : AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KY, ME, MA, MN, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI and WY., and Internationally to Canada.
- Lot, serial or model codes
- 4028110 - iLED Single; 4028210 - iLED duo; 4028310 - iLED trio/quad; 4038110 - TruLight single; 4038210 - TruLight duo; 4038310 - TruLight trio/quad; 1565068 - iLED single (TUSM); 1565160 - iLED duo (TUSM); 1565161 - iLED trio/quad (TUSM); 1574759 - TruLight single (TUSM); 1574850 - TruLight duo (TUSM); 1574851 - TruLight trio/quad (TUSM)
- 510(k) numbers
- ["K061317","K102758"]
- PMA numbers
- not on file
- Product code
- FSY
- Firm FEI
- 3003184737
- Firm city
- Charleston
- Firm state
- SC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28