Theralase Inc. Recalls

Overview of recall records associated with Theralase Inc., including dates, categories and classifications where available.

2recall records

Mar 4, 2020latest record date

Feb 26, 2020earliest record date

Recall history in this database

Classification mix: Class III: 2.

Medical DeviceMar 4, 2020

Theralase TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002 recall — FDA Z-1348-2020

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)…

Class IIIFDA: TerminatedTheralase Inc.

Medical DeviceFeb 26, 2020

Theralase TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the recall — FDA Z-1326-2020

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…

Class IIIFDA: TerminatedTheralase Inc.

Understanding this recall history

This page summarizes recall records in which the official source identifies Theralase Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.