TLC-2000 Therapeutic Medical Laser System recall
TLC-2000 Therapeutic Medical Laser System
Why was TLC-2000 Therapeutic Medical Laser System recalled?
905 nm laser diodes may be below rated power output.
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: 3245 to 3336 inclusive
- Product
- TLC-2000 Therapeutic Medical Laser System
- Recalling firm
- Theralase Inc.
- Quantity
- 92 units
- Distribution
- USA; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
- Recall date
- March 4, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)