TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
FDA device recall Z-1348-2020 · posted 2020-02-13 · Terminated
Recall details
- Recalling firm
- Theralase Inc.
- Reason for recall
- 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
- Action taken
- 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..
- Root cause
- Process control
- Status
- Terminated
- Product code
- NHN
- Quantity affected
- 202 units
- Distribution
- U.S.A.; 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
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 |