Helion S Exam Light or H300 The device is intended to recall
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…
Why was Helion S Exam Light or H300 The device is intended to recalled?
Possible fatigue failure of the plastic joint may occur after an average use of seven years.
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?
Unknown
- 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…
- Recalling firm
- Trumpf Medical Systems, Inc.
- Quantity
- 287
- Distribution
- US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.
- Recall date
- December 18, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)