Theralase Inc.: Medical Device Recall in 2020 - (Recall #: Z-1348-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: September 26, 2019

Date Posted: March 4, 2020

Recall Number: Z-1348-2020

Event ID: 84842

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

Status: Terminated

Product Quantity: 202 units

Code Information:

Serial Numbers: 3104-3106 (inclusive); 3109 to 3141 (inclusive), 3143, 3146, 3147, 3155, 3158, 3159, 3163-3165 (inclusive), 3168-3173 (inclusive), 3180-3184 (inclusive), 3188-3332 (inclusive), 3334

Distribution Pattern:

U.S.A.; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania

Voluntary or Mandated:

Voluntary: Firm initiated