ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K

FDA device recall Z-1122-2009 · posted 2009-04-01 · Terminated

Recall details

Recalling firm

Trumpf Medical Systems, Inc.

Reason for recall

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.

Action taken

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 facility will rise to the highest priority. Additionally, TRUMPF will issue a new approved cleaning and disinfection instruction, since investigations have shown that the cracking is significantly influenced by the use of certain disinfectants containing alcohol. The operator manual previously stated to avoid using alcohol-based cleaners on some parts of the ILED, but after reviewing this it was determined that it was not clearly stated to avoid use on the covers.

Root cause

Other

Status

Terminated

Product code

FSY

Quantity affected

4480 units (540 in U.S.)

Distribution

Worldwide Distribution.

Date initiated

2009-02-27

Date posted

2009-04-01

Date terminated

2009-10-22

Location

Charleston, SC

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