FDA recall Z-1348-2020

Product

TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002

Reason for recall

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

Key facts

Status

Terminated

Initiation date

2019-09-26

Report date

2020-03-04

Termination date

2020-12-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

East York, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1348-2020