Z-0484-2014Class II

Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's...

Name: Z-0484-2014 Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's...
Creator: Trumpf Medical Systems, Inc.
Published: 2013-02-19
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2013-02-19 / Terminated / root cause: manufacturing process

FDA source

Trumpf Medical Systems, Inc. began a recall of Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or... on 2013-02-19. FDA classified it as Class II and gives the reason as "Possible fatigue failure of the plastic joint may occur after an average use of seven years". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0484-2014
Classification: Class II
Status: Terminated
Initiated: 2013-02-19
Posted: 2013-12-12
Terminated: 2017-03-06
Recalling firm: Hill-Rom Inc.
Product: Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: Possible fatigue failure of the plastic joint may occur after an average use of seven years.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: TRUMPF sent an Urgent Recall Notice dated February 19, 2013, to all US affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The recall notice instructed customers to verify if they still have these light systems, and if they do have the light system verify if they have a metal or plastic ring at the joint of concern (per the manufacturer's Safety Notice). TRUMPF will directly work with affected customers to replace the affected arm system. For further questions please call ( 888 ) 474-9359.
Quantity in commerce: 287
Distribution: US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.
Product codes and lots: Unknown

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0484-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0484-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-12

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)