East York, Canada
Theralase Inc. recalls
6 recalls recorded since 2018, most recently on 26 September 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)0
Terminated or completed6
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 26 September 2019
- Terminated
- 3 December 2020
- Reason
- Device was shipped without a Unique Device Identification (UDI) label.
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0606-2020, Z-0607-2020
- TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
- TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
Terminated Class III Medical devices
- Recall started
- 26 September 2019
- Terminated
- 3 December 2020
- Reason
- 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)
- Distribution
- Worldwide distribution - US Nationwide and countries Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1326-2020
- TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
Terminated Class III Medical devices
- Recall started
- 26 September 2019
- Terminated
- 3 December 2020
- Reason
- 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
- Distribution
- U.S.A.; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1348-2020
- TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Terminated Class III Medical devices
- Recall started
- 26 September 2019
- Terminated
- 3 December 2020
- Reason
- Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard
- Distribution
- Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1266-2020
- TLC-2000 Therapeutic Medical Laser System
Terminated Class III Medical devices
- Recall started
- 26 September 2019
- Terminated
- 4 June 2020
- Reason
- 905 nm laser diodes may be below rated power output.
- Distribution
- USA; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1354-2020
- TLC-2000 Therapeutic Medical Laser System
Terminated Class III Medical devices
- Recall started
- 26 September 2019
- Terminated
- 3 December 2020
- Reason
- 660 nm laser diodes may be below rated power output.
- Distribution
- USA; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1353-2020
- TLC-2000 Therapeutic Medical Laser System
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.