Trumpf Medical Systems Recalls Helion and Xenion Surgical Lights
Trumpf Medical Systems is recalling 275 Helion and Xenion surgical lights due to reported fractures of the front joint of the spring arm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with reported mechanical fractures (structural defect) but no reported injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Trumpf Medical Systems, Inc. is recalling 275 units of Helion and Xenion surgical lights, specifically the 501/01 series KLM lights. These devices are intended to locally illuminate an operating or examination area of a patient's body with high-intensity light.
The recall is being conducted because incidents regarding fractures of the front joint of the spring arm have been reported. The affected units are identified by the Ondal AC2000 serial range of the spring arms, specifically from 0111 010 xxxxxx to 0111 066 xxxxx, which corresponds to units manufactured between January 2000 and June 2006.
The recalled products were distributed nationwide in the United States, including in the states of AR, CA, CO, CT, FL, GA, IL, KS, MA, MI, MO, NC, NJ, NY, OH, SC, TX, UT, VT, and WI. Users should contact Trumpf Medical Systems for further instructions regarding the rework of the affected spring arms.
The recalled product
- 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.
- Manufacturer
- Trumpf Medical Systems, Inc.
- Affected units
- 275
Distribution
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