Product Wiki · Recalls · Health Canada — Medical Devices

TLC-2000 System - Laser Probe, Power Pack, Power Supply (2019-09-26) — recall 44581

Health Canada — Medical Devices · Canada · 2019-10-11 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
44581
Date of alert
2019-10-11
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Power pack was shipped with a label identifying it as being CE compliant despite not receiving the CE mark yet. Power pack was shipped without a unique device identification label. Power pack 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. 905 nm laser diodes may be below rated power output. 660 nm laser diodes may be below rated power output. Power supply meets 4th edition specification of UL/EN/IEC-60601-1-2 instead of 3rd edition. Laser probe electromagnetic interference in excess of IEC-60601-1-2 (4th edition) standard.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/tlc-2000-system-laser-probe-po

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