FDA Medical Device Recalls (openFDA)
Trumpf Medical Systems, Inc.: Surgical lighting systems iLED and TruLight in use with the ALC+ function. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
- Recall number
- Z-1010-2012
- Recalling firm
- Trumpf Medical Systems, Inc.
- Product
- Surgical lighting systems iLED and TruLight in use with the ALC+ function. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
- Status
- Terminated
- Initiated
- 2012-01-09
- Posted
- 2012-02-13
- Terminated
- 2012-10-09
- Reason
- The ALC+ function may not be properly locked during use resulting in the possibility of the handle falling off into the surgical field causing injury to the patient.
- Root cause
- Device Design
- Action
- The firm, TRUMPF Medical Systems, Inc., sent an "Urgent Safety Information" notice/package dated January 9, 2012 to its customers. (Note: Some were delivered by TRUMPF representatives in person and some via mail with Urgent Safety identification on the envelope). The notice describes the product, problem and actions to be taken. TRUMPF will replace all sterilizable handles of this type in the field with new handles, in addition, TRUMPF will send new handles and verify disposal of the old version at the customers location. Distribution of new handles will start January 2012. The customers were instructed to ensure that all users and other relevent persons are informed of the Urgent Safety Information; store the information until the measure has been completed and complete and return the Confirmation of User Receipt form via mail to TRUMPF Medical Systems, Inc. 1046 LeGrand Blvd., Charleston, SC 29063 or email: Lindsey.ronnenberg@us.trumpf-med.com. If you have any questions, call 843-822-6939.
- Quantity
- 8,733 units
- Distribution
- Worldwide distribution: USA (nationwide) including states of: AL, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MO, NC, NM, NJ, NY, OH, PA, TX, VA, VT, WA, and WI; and countries of: Australia; Austria, Belguim, China, Cyprus, Denmark, Estonia, Finland, France, Germany, Great Britain, Hong Kong, Indonesia, India, Ireland, Italy, Japan, Kazakhstan, Kenya, Korea, Latvia, Luxembourg, Mexico, Netherlands, Norway, Pakistan, Peru, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Seychelles, Singapore, South Africa (Zuid Afirka), Spain, Sweden, Switzerland (Confederation of Helvetia), Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam.
- Lot, serial or model codes
- Material number 1583966
- 510(k) numbers
- ["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