TLC-2000 Therapeutic Medical Laser System recall
TLC-2000 Therapeutic Medical Laser System
Why was TLC-2000 Therapeutic Medical Laser System recalled?
Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard
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?
Serial Numbers: 3333 to 3350 (inclusive)
- Product
- TLC-2000 Therapeutic Medical Laser System
- Recalling firm
- Theralase Inc.
- Quantity
- 18 units
- Distribution
- Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
- Recall date
- February 26, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)