Z-0563-2016Class II

Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5

Name: Z-0563-2016 Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
Creator: Trumpf Medical Systems, Inc.
Published: 2015-11-02
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2015-11-02 / Completed

FDA source

Trumpf Medical Systems, Inc. began a recall of Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5 on 2015-11-02. FDA classified it as Class II and gives the reason as "The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head...". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-0563-2016
Classification: Class II
Status: Completed
Initiated: 2015-11-02
Posted: 2015-12-31
Recalling firm: Hill-Rom Inc.
Product: Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.
FDA root cause: Other
Action: TRUMPF sent an " Urgent Field Safety Information" letter dated December 8, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by the customer: 1. Perform an inspection of the lighting systems (see Appendix 1 for instructions). If any of the symptoms listed below are observed, immediately remove the light from operation and contact your Trumpf Medical Service Representative or designee. Signs that indicate a possible fall of the spring arm: The movement of the light and spring arm is difficult for the user, The lights have stopped being operational, and/or A gap is noticed between the spring arm and the central axis (see the attached Appendix 1 for an example). 2. Follow the User Manual: No unauthorized servicing of the spring arm is permitted. Snap rings are one use only and replacements must be purchased from your authorized Trumpf Medical partner. If you have any questions concerning this request or the procedure as outlined, please contact TRUMPF Medical Systems, Inc. at 888-474-9359
Quantity in commerce: 20,713
Distribution: USA (nationwide) Distribution to the states of : AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KY, ME, MA, MN, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI and WY., and Internationally to Canada.
Product codes and lots: 4028110 - iLED Single; 4028210 - iLED duo; 4028310 - iLED trio/quad; 4038110 - TruLight single; 4038210 - TruLight duo; 4038310 - TruLight trio/quad; 1565068 - iLED single (TUSM); 1565160 - iLED duo (TUSM); 1565161 - iLED trio/quad (TUSM); 1574759 - TruLight single (TUSM); 1574850 - TruLight duo (TUSM); 1574851 - TruLight trio/quad (TUSM)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0563-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0563-2016	Class II	Completed	Voluntary: Firm initiated	2016-01-06	2015-12-31

Product code FSY

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)