Z-1010-2012

Surgical lighting systems iLED and TruLight in use with the ALC+ function. The TRUMPF surgical lights are...

Name: Z-1010-2012 Surgical lighting systems iLED and TruLight in use with the ALC+ function. The TRUMPF surgical lights are...
Creator: Trumpf Medical Systems, Inc.
Published: 2012-01-09
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2012-01-09 / Terminated / root cause: design

FDA source

Trumpf Medical Systems, Inc. began a recall of Surgical lighting systems iLED and TruLight in use with the ALC+ function. The TRUMPF surgical lights are intended to locally illuminate an operating or... on 2012-01-09. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1010-2012
Status: Terminated
Initiated: 2012-01-09
Posted: 2012-02-13
Terminated: 2012-10-09
Recalling firm: Hill-Rom 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.
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: 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 tag: design
FDA 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: [email protected]. If you have any questions, call 843-822-6939.
Quantity in commerce: 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.
Product codes and lots: Material number 1583966

Product code FSY

K102758Class IITrulight 5520 and Trulight 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg / cleared 2010-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)