FDA Medical Device Recalls (openFDA)
Trumpf Medical Systems, Inc.: ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K
- Recall number
- Z-1122-2009
- Recalling firm
- Trumpf Medical Systems, Inc.
- Product
- ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K
- Status
- Terminated
- Initiated
- 2009-02-27
- Posted
- 2009-04-01
- Terminated
- 2009-10-22
- Reason
- Cracks may form around the screw connections of the cover plates causing brittleness, which may lead to fragments breaking off and falling into the operating area.
- Root cause
- Other
- Action
- Consignees were notified via an Urgent Safety Information letter starting 02/27/2009. The Recall Notice asks customers to visually inspect the ILED covers for cracks and in particular to focus on the corners. If cracking is visible they are asked to remedy by taping with a clear tape over the cracks and report it to TRUMPF Medical Systems, Inc. immediately. TRUMPF will be replacing all covers with a newly designed and tested cover. Original priority in the United States will be set to start with the oldest units affected. If TRUMPF receives notification that cracking does exist then that facility will rise to the highest priority. Additionally, TRUMPF will issue a new approved cleaning and disinfection instruction, since investigations have shown that the cracking is significantly influenced by the use of certain disinfectants containing alcohol. The operator manual previously stated to avoid using alcohol-based cleaners on some parts of the ILED, but after reviewing this it was determined that it was not clearly stated to avoid use on the covers.
- Quantity
- 4480 units (540 in U.S.)
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- Serial numbers: 100268621 to 100717475
- 510(k) numbers
- ["K061317"]
- 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