Z-0077-2013 Class II Terminated
FDA device recall Z-0077-2013 was initiated by Trumpf Medical Systems, Inc. on Sep 19, 2012 and is designated Class II. Reason for recall: Incidents regarding fractures of the front joint of the spring arm have been reported. The recall status is terminated (terminated Jan 21, 2014). Affected quantity: 275 units.
Recall details
- Product Type
- Devices
- Report Date
- Oct 24, 2012
- Initiation Date
- Sep 19, 2012
- Termination Date
- Jan 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 275 units
Product description
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.
Reason for recall
Incidents regarding fractures of the front joint of the spring arm have been reported.
Distribution pattern
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.
Code information
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).
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0077-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026