# FDA recall Z-1326-2020

> **Theralase Inc.** · Class III · device recall initiated 2019-09-26.

## Product

TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.

## Reason for recall

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.

## Key facts

- **Recall number:** Z-1326-2020
- **Recalling firm:** Theralase Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-26
- **Report date:** 2020-02-26
- **Termination date:** 2020-12-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East York, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1326-2020

## Citation

> AI Analytics. FDA recall Z-1326-2020. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1326-2020. Source: US FDA. Licensed CC0.

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