FDA Medical Device Recalls (openFDA)
Theralase Inc.: TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
- Recall number
- Z-0606-2020
- Recalling firm
- Theralase Inc.
- Product
- TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
- Status
- Terminated
- Initiated
- 2019-09-26
- Posted
- 2019-12-05
- Terminated
- 2020-12-03
- Reason
- Device was shipped without a Unique Device Identification (UDI) label.
- Root cause
- Process control
- Action
- On September 26, 2019 the firm distributed Urgent Medical Device Recall Communication letters. Check the Serial Number on your TLC-2000 Power Pack (Model Number: TLC-2002) to see if your TLC-2000 is affected by the following issues: 1) The TLC-2000 Power Pack was shipped with a label identifying it as being CE compliant. What Should You Do?: No action required. The TLC-2000 is approved for sale in Canada under Medical Device License Number: 98357. The TLC-2000 is cleared for sale in the United States by the FDA under 510(k) number: K151816. *Product with Serial Number 3204 was sold in the European Union. Only the owner of Serial Number 3204 should return their TLC-2000. 2)The TLC-2000 was shipped without a Unique Device Identification (UDI) label. What Should You Do?: Please courier your TLC-2000 to Theralase, at your cost, for update. A UDI label will be added to your TLC-2000, at no charge and your TLC-2000 will be couriered back to you at Theralase's cost.
- Quantity
- 41 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, LA, MD, MN, NC, NJ, NM, NY, OR, WI and countries of AU, BH, CA, HK, JO, MX, PK, PH.
- Lot, serial or model codes
- Serial Numbers: 3015, 3022, 3037, 3040, 3047, 3052, 3055, 3074, 3076, 3080, 3100, 3101, 3102, 3103, 3123, 3127, 3129, 3131, 3132, 3137, 3139, 3155, 3162, 3166, 3171, 3183, 3187, 3200, 3206, 3227, 3245, 3266, 3268, 3293, 3296, 3297, 3305, 3308, 3318, 3321, 3332
- 510(k) numbers
- ["K151816"]
- PMA numbers
- not on file
- Product code
- NHN
- Firm FEI
- 3003614490
- Firm city
- East York
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28