Theralase Recalls
7 recalls on record · December 11, 2019 to March 4, 2020 · Medical Devices
Recalls by year
19
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 4, 2020Medical DevicesFDA
Theralase Inc. recalls TLC-2000 Therapeutic Medical Laser System
Hazard: 905 nm laser diodes may be below rated power output.
March 4, 2020Medical DevicesFDA
Theralase Inc. recalls TLC-2000 Therapeutic Medical Laser System
Hazard: 660 nm laser diodes may be below rated power output.
March 4, 2020Medical DevicesFDA
Theralase Inc. recalls TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Hazard: 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
February 26, 2020Medical DevicesFDA
Theralase Inc. recalls TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
Hazard: Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped versus Power supply (Model Number: TLC-2003) MENB1100A2403F01 (24 VDC, 4.2 A, 101 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 3rd edition specification)
February 26, 2020Medical DevicesFDA
Theralase Inc. recalls TLC-2000 Therapeutic Medical Laser System
Hazard: Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard
December 11, 2019Medical DevicesFDA
Theralase Inc. recalls TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
Hazard: 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.
December 11, 2019Medical DevicesFDA
Theralase Inc. recalls TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
Hazard: Device was shipped without a Unique Device Identification (UDI) label.