Z-1266-2020 Class III Terminated
FDA device recall Z-1266-2020 was initiated by Theralase Inc. on September 26, 2019 and is designated Class III. Reason for recall: Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard The recall status is terminated (terminated December 3, 2020). Affected quantity: 18 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- September 26, 2019
- Termination Date
- December 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
Product Description
TLC-2000 Therapeutic Medical Laser System
Reason for Recall
Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard
Distribution Pattern
Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
Code Information
Serial Numbers: 3333 to 3350 (inclusive)