Z-1122-2009

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

Name: Z-1122-2009 ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K
Creator: Trumpf Medical Systems, Inc.
Published: 2009-02-27
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2009-02-27 / Terminated

FDA source

Trumpf Medical Systems, Inc. began a recall of ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K on 2009-02-27. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1122-2009
Status: Terminated
Initiated: 2009-02-27
Posted: 2009-04-01
Terminated: 2009-10-22
Recalling firm: Hill-Rom Inc.
Product: ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K
Product code: FSY Light, Surgical, Ceiling Mounted
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.
FDA 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 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.
Quantity in commerce: 4480 units (540 in U.S.)
Distribution: Worldwide Distribution.
Product codes and lots: Serial numbers: 100268621 to 100717475

Product code FSY

K061317Class IIIledTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg / cleared 2006-06-22

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)