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

Starting date:
September 26, 2019
Posting date:
October 11, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-71275

Last updated:

Affected Products

A. TLC-2000 System - Laser Probe
B. TLC-2000 System - Power Pack
C. TLC-2000 System - Power Supply

Reason

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.

Affected products

A. TLC-2000 System - Laser Probe

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • TLC-2001
Companies
Manufacturer
THERALASE TECHNOLOGIES INC.
41 Hollinger Rd.
East York
M4B 3G4
Ontario
CANADA

B. TLC-2000 System - Power Pack

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number
  • TLC-2002
Companies
Manufacturer
THERALASE TECHNOLOGIES INC.
41 Hollinger Rd.
East York
M4B 3G4
Ontario
CANADA

C. TLC-2000 System - Power Supply

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • TLC-2003
Companies
Manufacturer
THERALASE TECHNOLOGIES INC.
41 Hollinger Rd.
East York
M4B 3G4
Ontario
CANADA