Helion and Xenion surgical lights recall
Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area…
Why was Helion and Xenion surgical lights recalled?
Incidents regarding fractures of the front joint of the spring arm have been reported.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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).
- Product
- Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area…
- Recalling firm
- Trumpf Medical Systems, Inc.
- Quantity
- 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.
- Recall date
- October 24, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)