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

FDA device recall Z-1010-2012 · posted 2012-02-13 · Terminated

Recall details

Recalling firm

Trumpf Medical Systems, Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

FSY

Quantity affected

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, Belg

Date initiated

2012-01-09

Date posted

2012-02-13

Date terminated

2012-10-09

Location

Charleston, SC

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