Z-0077-2013Class II

Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally...

Name: Z-0077-2013 Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally...
Creator: Trumpf Medical Systems, Inc.
Published: 2012-09-19
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2012-09-19 / Terminated / root cause: design

FDA source

Trumpf Medical Systems, Inc. began a recall of Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the... on 2012-09-19. FDA classified it as Class II and gives the reason as "Incidents regarding fractures of the front joint of the spring arm have been reported". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0077-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-19
Posted: 2012-10-18
Terminated: 2014-01-21
Recalling firm: Hill-Rom Inc.
Product: Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: Incidents regarding fractures of the front joint of the spring arm have been reported.
Root cause tag: design
FDA root cause: Device Design
Action: Trumpf sent an "URGENT RECALL NOTICE" dated September 19, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Confirmation of Receipt Form was attached for customers to complete and return. Contact the firm at 888-474-9359 for questions regarding this notice.
Quantity in commerce: 275 units
Distribution: Nationwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, IL, KS, MA, MI, MO, NC, NJ, NY, OH, SC, TX, UT, VT and WI.
Product codes and lots: Ondal AC2000 serial range of the spring arms requiring rework: 0111 010 xxxxxx to 0111 066 xxxxx (010 to 066 = month 01/year 20000 to month 06/year 2006 xxxxxx = 5 digit serial number).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0077-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0077-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18

Product code FSY

K011693Class IITrumpf Surgical Lights, Models 301,501,701,1001Trumpf Medical Systems, Inc. / cleared 2001-06-13

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)