Home / Recalls / Medical Devices
Theralase Inc. recalls TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Recalled March 4, 2020 · FDA recall Z-1348-2020 · Theralase
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 · FDA Class III
Units
202 units
Sold at
U.S.A.; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
Description
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
Product
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Manufacturer(s)
Theralase Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →