Trumpf Medical Systems Recalls Helion S and H300 Exam Lights
Trumpf Medical Systems is recalling 287 Helion S and H300 exam lights because a plastic joint may fail due to fatigue after seven years of use.
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 risk-of-harm product (medical device structural failure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Trumpf Medical Systems, Inc. is recalling 287 units of the Helion S Exam Light and H300 exam light. These devices are intended to locally illuminate an examination area of a patient's body with high-intensity light in clinical or doctor's practice settings.
The recall is being issued because a possible fatigue failure of the plastic joint may occur after an average use of seven years. The affected units were distributed in the United States, including the states of Arkansas, California, Colorado, Kansas, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, and Washington.
The source text does not specify specific actions for consumers or healthcare providers to take, nor does it report any injuries or illnesses associated with this defect.
The recalled product
- 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.
- Manufacturer
- Trumpf Medical Systems, Inc.
- Hazard
- Affected units
- 287
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Unknown
Distribution
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