TLC-2000 Therapeutic Medical Laser System
FDA device recall Z-1354-2020 · posted 2020-02-13 · Terminated
Recall details
- Recalling firm
- Theralase Inc.
- Reason for recall
- 905 nm laser diodes may be below rated power output.
- 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 for analysis. Their 905 nm laser diodes will be analyzed and recalibrated, as required, to meet rated power output.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NHN
- Quantity affected
- 92 units
- Distribution
- USA; 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
- 2020-06-04
- Location
- East York, Canada
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TLC-2000 Therapeutic Medical Laser System (K151816) | Theralase, Inc. | 2015-11-19 |