TLC-2000 Therapeutic Medical Laser System Power Pack recall
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Why was TLC-2000 Therapeutic Medical Laser System Power Pack recalled?
Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) standards; however, not tested to IEC-60601-1-2 (3rd edition) standards
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: 3104-3106 (inclusive); 3109 to 3141 (inclusive), 3143, 3146, 3147, 3155, 3158, 3159, 3163-3165 (inclusive), 3168-3173 (inclusive), 3180-3184 (inclusive), 3188-3332 (inclusive), 3334
- Product
- TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
- Recalling firm
- Theralase Inc.
- Quantity
- 202 units
- Distribution
- U.S.A.; 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)