Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0607-2020 — TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.

U.S. FDA — Device Enforcement · Canada · 2019-09-26 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0607-2020
Date of alert
2019-09-26
Country / jurisdiction
Canada
Risk level
Class III
Risk type
recall
Brand
Theralase Inc.
Product category
device
Product type
Devices
Reported risk: Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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