FDA Medical Device Recalls (openFDA)
Theralase Inc.: TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
- Recall number
- Z-1348-2020
- Recalling firm
- Theralase Inc.
- Product
- TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
- Status
- Terminated
- Initiated
- 2019-09-26
- Posted
- 2020-02-13
- Terminated
- 2020-12-03
- Reason
- 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
- Root cause
- Process control
- Action
- Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Please courier your TLC-2000 to Theralase, at your cost, for modification. A Field Inspection Test will be completed and once passed, a Special Inspections for Medical Electrical Equipment and Systems label will be applied to your TLC-2000 Power Pack..
- Quantity
- 202 units
- Distribution
- U.S.A.; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
- Lot, serial or model codes
- 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
- 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