Z-0484-2014 Class II Terminated
FDA device recall Z-0484-2014 was initiated by Trumpf Medical Systems, Inc. on Feb 19, 2013 and is designated Class II. Reason for recall: Possible fatigue failure of the plastic joint may occur after an average use of seven years. The recall status is terminated (terminated Mar 6, 2017). Affected quantity: 287.
Recall details
- Product Type
- Devices
- Report Date
- Dec 18, 2013
- Initiation Date
- Feb 19, 2013
- Termination Date
- Mar 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 287
Product description
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.
Reason for recall
Possible fatigue failure of the plastic joint may occur after an average use of seven years.
Distribution pattern
US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.
Code information
Unknown
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0484-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026