Z-0607-2020 Class III Terminated
FDA device recall Z-0607-2020 was initiated by Theralase Inc. on September 26, 2019 and is designated Class III. Reason for recall: Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark. The recall status is terminated (terminated December 3, 2020). Affected quantity: 306 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2019
- Initiation Date
- September 26, 2019
- Termination Date
- December 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 306 units
Product Description
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
Reason for Recall
Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, LA, MD, MN, NC, NJ, NM, NY, OR, WI and countries of AU, BH, CA, HK, JO, MX, PK, PH.
Code Information
Serial Numbers on TLC-2002 Power Pack with CE Mark without CE approval: 3012 to 3204, inclusive; and 3202 to 3350 inclusive. Serial Number 3204 was sold abroad