Recall Z-1010-2012 ยท FSY Light, Surgical, Ceiling Mounted
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.
| Date | Feb 13, 2012 (initiated Jan 9, 2012) |
| Status | Terminated |
| 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 we |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102758 | TRULIGHT 5520 AND TRULIGHT 5320 Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg, Oct 26, 2010 |