TLC-2000 Therapeutic Medical Laser System
FDA device recall Z-1266-2020 · posted 2020-02-13 · Terminated
Recall details
- Recalling firm
- Theralase Inc.
- Reason for recall
- Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard
- 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. The TLC-2000 will be updated to reduce EMI to meet IEC 60601-1-2 standard (4th edition).
- Root cause
- Process control
- Status
- Terminated
- Product code
- NHN
- Quantity affected
- 18 units
- Distribution
- 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 |