TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
FDA device recall Z-1326-2020 · posted 2020-02-13 · Terminated
Recall details
- Recalling firm
- Theralase Inc.
- Reason for recall
- Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped versus Power supply (Model Number: TLC-2003) MENB1100A2403F01 (24 VDC, 4.2 A, 101 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 3rd edition specification)
- Action taken
- Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Healthcare practitioners are instructed to courier their TLC-2000 to Theralase. A Field Inspection Test will be completed and once passed, a Special Inspections for Medical Electrical Equipment and Systems label will be applied to the TLC-2000.The Field Inspection Test will be completed according to either CSA 60601-1 or UL 60601-1 dependent upon the customers Canadian or United States location, respectively.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NHN
- Quantity affected
- 76 units
- Distribution
- Worldwide distribution - US Nationwide and countries Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania.
- Date initiated
- 2019-09-26
- Date posted
- 2020-02-13
- Date terminated
- 2020-12-03
- Location
- East York, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TLC-2000 Therapeutic Medical Laser System (K151816) | Theralase, Inc. | 2015-11-19 |