Recall Z-1122-2009 ยท FSY Light, Surgical, Ceiling Mounted
Trumpf Medical Systems, Inc.
ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K
| Date | Apr 1, 2009 (initiated Feb 27, 2009) |
| Status | Terminated |
| 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 faci |
| Quantity | 4480 units (540 in U.S.) |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061317 | ILED Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg, Jun 22, 2006 |